Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- K250136Globalcare Blood Pressure Monitor (GUS610)2Cleared 510(K)
- K250091KOROT Blood Pressure Monitor (KOROT P3 Accurate)2Cleared 510(K)
- K243115Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))2Cleared 510(K)
- K241578Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)2Cleared 510(K)
- K241634Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)2Cleared 510(K)
- K243661Electronic Blood Pressure Monitor2Cleared 510(K)
- K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)2Cleared 510(K)
- K241590Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)2Cleared 510(K)
- K242568Wrist Blood Pressure Monitor (OHMS11, OHMS12)2Cleared 510(K)
- K241728Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 20502Cleared 510(K)
- K241066BB-613-BPM2Cleared 510(K)
- K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)2Cleared 510(K)
- K242528Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)2Cleared 510(K)
- K243118Arm Blood Pressure Monitor (model: BPM-A7VL)2Cleared 510(K)
- K241007Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)2Cleared 510(K)
- K242193Arm Type Blood Pressure Monitor (BPM82)2Cleared 510(K)
- K241613Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)2Cleared 510(K)
- K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)2Cleared 510(K)
- K241351Blood Pressure Monitor (TMB-2092-G)2Cleared 510(K)
- K241129Upper Arm Electronic Blood Pressure Monitor2Cleared 510(K)
- K240729Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)2Cleared 510(K)
- K240832Blood Pressure Monitor (BBZ32-AA01)2Cleared 510(K)
- K240254Blood Pressure Monitor (TMB-2296-BT)2Cleared 510(K)
- K240102Blood Pressure Monitor (TMB-2287-B)2Cleared 510(K)
- K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)2Cleared 510(K)
- K231984Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)2Cleared 510(K)
- K233146Blood Pressure Monitor2Cleared 510(K)
- K233799Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)2Cleared 510(K)
- K231303Arm-type Fully Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K230996Pursuant Health Kiosk (G1.D5)2Cleared 510(K)
- K233130Blood Pressure Monitor2Cleared 510(K)
- K231478Digital Blood Pressure Monitor (Model: YB-800)2Cleared 510(K)
- K232815Wrist Blood Pressure Monitor2Cleared 510(K)
- K232053SimpleSense-BP, SimpleSense-BP Software Application2Cleared 510(K)
- K232814Electronic Blood Pressure Monitor2Cleared 510(K)
- K223170Electronic Blood Pressure Monitor, model: HTD6602US2Cleared 510(K)
- K232713Blood Pressure Monitor2Cleared 510(K)
- K231250Digital Blood Pressure Monitor2Cleared 510(K)
- K232621Blood pressure monitor2Cleared 510(K)
- K231245Digital Blood Pressure Monitor (Arm Type)2Cleared 510(K)
- K231310Electronic Blood Pressure Monitor2Cleared 510(K)
- K230919Acumen IQ finger cuff2Cleared 510(K)
- K231050Arm Blood Pressure Monitor2Cleared 510(K)
- K223873Boppli Infant Blood Pressure Monitor2Cleared 510(K)
- K231367Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)2Cleared 510(K)
- K231542Digital Blood Pressure Monitor WBP Series2Cleared 510(K)
- K230649Arm Blood Pressure Monitor2Cleared 510(K)
- K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K230409Wrist Type Blood Pressure Monitor (W05,W1101L)2Cleared 510(K)
- K230642Electronic Blood Pressure Monitor2Cleared 510(K)
- K231174BPBIO7502Cleared 510(K)
- K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B2Cleared 510(K)
- K223374Blood Pressure Monitor2Cleared 510(K)
- K230176Upper Arm Blood Pressure Monitor2Cleared 510(K)
- K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K2Cleared 510(K)
- K222658Accurate 24 Non-invasive blood pressure monitor2Cleared 510(K)
- K223291Electronic Blood Pressure Monitor2Cleared 510(K)
- K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W2Cleared 510(K)
- K222926Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B16832Cleared 510(K)
- K221742CONNEQT PULSE2Cleared 510(K)
- K223332Task Force CORE2Cleared 510(K)
- K222887Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor2Cleared 510(K)
- K222394Electronic Sphygmomanometers2Cleared 510(K)
- K222869Arm Blood Pressure Monitor2Cleared 510(K)
- K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)2Cleared 510(K)
- K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G2Cleared 510(K)
- K222160GUS610 Blood pressure monitor2Cleared 510(K)
- K221833HemoSphere Advanced Monitor, HemoSphere ClearSight Module2Cleared 510(K)
- K221372YUWELL Electronic Blood Pressure Monitor2Cleared 510(K)
- K221913Arm Blood Pressure Monitor2Cleared 510(K)
- K221764InBody Blood pressure monitor, Model BPBIO480KV2Cleared 510(K)
- K212168A&D Medical UM-212BLE Blood Pressure Monitor2Cleared 510(K)
- K220220Electronic Sphygmomanometer (Model: LT-P30)2Cleared 510(K)
- K213023Blood Pressure Monitor(Model:Y30001)2Cleared 510(K)
- K221040Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)2Cleared 510(K)
- K221486INDEX BPM2Cleared 510(K)
- K220676Blood Pressure Monitor2Cleared 510(K)
- K221212Upper Arm Blood Pressure Monitor2Cleared 510(K)
- K220886Upper Arm Type Blood Pressure Monitor2Cleared 510(K)
- K220651Wrist Type Blood Pressure Monitor2Cleared 510(K)
- K220106QardioArm 22Cleared 510(K)
- K220113Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)2Cleared 510(K)
- K201302LiveOne2Cleared 510(K)
- K213699CareTaker Monitor App2Cleared 510(K)
- K213189Wrist-type Fully Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E2Cleared 510(K)
- K212312RA-T59 Wrist blood pressure monitor2Cleared 510(K)
- K211532Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB332Cleared 510(K)
- K212877Arm Blood Pressure Monitor2Cleared 510(K)
- K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B2Cleared 510(K)
- K212171Electronic Blood Pressure Monitor2Cleared 510(K)
- K210563Arm Blood Pressure Monitor2Cleared 510(K)
- K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-092Cleared 510(K)
- K210152Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM2Cleared 510(K)
- K211041Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W16812Cleared 510(K)
- K211588Caretaker Platform, VitalStream Platform, CT52Cleared 510(K)
- K210671Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP1072Cleared 510(K)
- K210768Wrist Blood Pressure Monitor, Blood Pressure Monitor2Cleared 510(K)
- K210770Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor2Cleared 510(K)
- K201914HRVWatch-Mini Wrist Monitor2Cleared 510(K)
- K210435Automatic Arm Electronic Blood Pressure Monitor2Cleared 510(K)
- K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor2Cleared 510(K)
- K202729Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K202228Omron Model BP7900 Blood Pressure Monitor + EKG2Cleared 510(K)
- K202891Blood Pressure Monitor2Cleared 510(K)
- K201332Meditech ABPM-06 (BP6)2Cleared 510(K)
- K193387Arm Electronic Sphygmomanometer2Cleared 510(K)
- K193386Wrist Electronic Sphygmomanometer2Cleared 510(K)
- K202934Blood Pressure Monitor2Cleared 510(K)
- K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform2Cleared 510(K)
- K200560InBody2Cleared 510(K)
- K202372Upper Arm Electronic Blood Pressure Monitor2Cleared 510(K)
- K200346Wrist Type Blood Pressure Monitor2Cleared 510(K)
- K202599Transtek Wrist Blood Pressure Monitor2Cleared 510(K)
- K200716Electronic Blood Pressure Monitor2Cleared 510(K)
- K200442InBody2Cleared 510(K)
- K200434V20, V20a, AVSM3 SNF2Cleared 510(K)
- K201467Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B2Cleared 510(K)
- K200939Electronic Blood Pressure Monitor2Cleared 510(K)
- K200649Arm-Type Fully Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K200738Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K193456Arm Blood Pressure Monitor2Cleared 510(K)
- K193627Automatic Upper Arm Blood Pressure Monitor2Cleared 510(K)
- K193628AGE Automatic Wrist Blood Pressure Monitor2Cleared 510(K)
- K193624Automatic Upper Arm Blood Pressure Monitor2Cleared 510(K)
- K200437Blood Pressure Monitor2Cleared 510(K)
- K193348Blood Pressure Monitor2Cleared 510(K)
- K200297Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K200521Full Automatic(NIBP) Blood Pressure Monitor2Cleared 510(K)
- K190982Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K200287BP-BT Kiosk2Cleared 510(K)
- K191745Medtronic Commander Flex2Cleared 510(K)
- K192609Globalcare Blood Pressure Monitor2Cleared 510(K)
- K191894Upper Arm Blood Pressure Monitor2Cleared 510(K)
- K192092Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 5352Cleared 510(K)
- K192023Arm Blood Pressure Monitor2Cleared 510(K)
- K191673Upper Arm Blood Pressure Monitor2Cleared 510(K)
- K190507Full Automatic (NIBP) Blood Pressure Monitor2Cleared 510(K)
- K183521CNAP Monitor2Cleared 510(K)
- K192058EV1000 Clinical Platform NI, EV1000 Clinical Platform2Cleared 510(K)
- K191180Electronic Blood Pressure Monitor2Cleared 510(K)
- K190207Blood Pressure Monitor2Cleared 510(K)
- K190893Non-invasive Hemodynamic Blood Pressure Monitor2Cleared 510(K)
- K181154Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor2Cleared 510(K)
- K190886Non-invasive blood pressure measurement systems2Cleared 510(K)
- K191593Digital Automatic Blood Pressure Monitor MD36 Series2Cleared 510(K)
- K190818Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K183058Arm-type Electronic Blood Pressure Monitor2Cleared 510(K)
- K190927Oscillometric Blood Pressure Monitor2Cleared 510(K)
- K190130The ClearSight finger cuffs2Cleared 510(K)
- K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UB2Cleared 510(K)
- K183535Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TB2Cleared 510(K)
- K183534Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K173895Tel-O-Graph2Cleared 510(K)
- K181894TOF-Cuff monitor2Cleared 510(K)
- K173065A&D Medical Blood Pressure Monitors2Cleared 510(K)
- K190693HEM-6410T-ZL Wrist Blood Pressure Monitor2Cleared 510(K)
- K181832Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device2Cleared 510(K)
- K181931GMC Upper Arm Automatic Blood Pressure Monitor2Cleared 510(K)
- K183491Arm Blood Pressure Monitor2Cleared 510(K)
- K173191A&D Medical Blood Pressure Monitors2Cleared 510(K)
- K182579Omron Model BP7900 Blood Pressure Monitor + EKG2Cleared 510(K)
- K183469Microlife Digital Blood Pressure Monitor2Cleared 510(K)
- K182495Electronic Blood Pressure Monitor2Cleared 510(K)
- K181930GMC Wrist Automatic Blood Pressure Monitor2Cleared 510(K)
- K182934FORA P100 Blood Pressure Monitoring System2Cleared 510(K)
- K180435Arm Blood Pressure Monitor2Cleared 510(K)
- K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System2Cleared 510(K)
- K182481HEM-6410T-ZM Wrist Blood Pressure Monitor2Cleared 510(K)
- K182166Wrist Blood Pressure Monitor Model BP43502Cleared 510(K)
- K173916Finapres Nova Noninvasive Hemodynamic Monitor2Cleared 510(K)
- K182127Wrist Blood Pressure Monitor Model BP61002Cleared 510(K)
- K180240Full Automatic(NIBP) Blood Pressure Monitor2Cleared 510(K)
- K182018Bluetooth blood pressure monitor2Cleared 510(K)
- K181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style2Cleared 510(K)
- K173024Non-invasive blood pressure measurement systems2Cleared 510(K)
- K180155Arm Type Blood Pressure Monitor2Cleared 510(K)
- K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software2Cleared 510(K)
- K172895AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-8192Cleared 510(K)
- K172880Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K171379Digital Automatic Wrist Blood Pressure Monitor MD43002Cleared 510(K)
- K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D2Cleared 510(K)
- K171937Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K162616Wrist Type Blood Pressure Monitor2Cleared 510(K)
- K172972Wrist Type Automatic Blood Pressure Monitor2Cleared 510(K)
- K171668Bluetooth blood pressure monitor2Cleared 510(K)
- K170866Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-5792Cleared 510(K)
- K172896Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC3122Cleared 510(K)
- K171833Digital Blood Pressure Monitor-Wrist Style2Cleared 510(K)
- K170497V102Cleared 510(K)
- K170666The Wrist-Type Fully Automatic Digital Blood Pressure Monitors2Cleared 510(K)
- K170545Automatic Wrist Bluetooth Blood Pressure Monitor2Cleared 510(K)
- K170466Automatic Blood Pressure Monitor Model LD-518 & LD-5372Cleared 510(K)
- K170454Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U2Cleared 510(K)
- K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y2Cleared 510(K)
- K170151Electronic Blood Pressure Monitor2Cleared 510(K)
- K172739higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)2Cleared 510(K)
- K170467Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K171062BP5S Wireless Blood Pressure Monitor2Cleared 510(K)
- K161845Electronic Blood Pressure Monitor2Cleared 510(K)
- K171282Fully Automatic Blood Pressure Monitor2Cleared 510(K)
- K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series2Cleared 510(K)
- K170966TONOPORT VI2Cleared 510(K)
- K163679Digital Automatic Blood Pressure Monitor MD36002Cleared 510(K)
- K162463Matrix Data Management System2Cleared 510(K)
- K170196A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor2Cleared 510(K)
- K163276Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K163606Digital Blood Pressure Monitor-Automatic Upper Arm Style2Cleared 510(K)
- K163683A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor2Cleared 510(K)
- K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor2Cleared 510(K)
- K163235HEM-9210T2Cleared 510(K)
- K160967Finapres Nova Noninvasive Hemodynamic Monitor2Cleared 510(K)
- K161712Arm automatic blood pressure monitor2Cleared 510(K)
- K161530Bluetooth blood pressure monitor2Cleared 510(K)
- K153600Consult Station TS2Cleared 510(K)
- K163045Omron HEM-6400T-Z Wrist Blood Pressure Monitor2Cleared 510(K)
- K162668Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K162089Blood Pressure Monitor2Cleared 510(K)
- K162915Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K161577Arm-Type Fully Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K162144iHealth Wireless Blood Pressure Monitor2Cleared 510(K)
- K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series2Cleared 510(K)
- K162092Evolv Model BP7000 Upper Arm Blood Pressure Monitor2Cleared 510(K)
- K161708Arm automatic blood pressure monitor2Cleared 510(K)
- K162230Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K160349Electronic Sphygmomanometer2Cleared 510(K)
- K161846Automatic Arm Bluetooth Blood Pressure Monitor2Cleared 510(K)
- K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device2Cleared 510(K)
- K162338Full Automatic (NIBP) Blood Pressure Monitor2Cleared 510(K)
- K152659V102Cleared 510(K)
- K160565Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K160563Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K153557ABPM 7100, Hypertension Management Software2Cleared 510(K)
- K160557Full Automatic (NIBP) Blood Pressure Monitor2Cleared 510(K)
- K160439SunTech CT40 Spot-check Vital Signs Device2Cleared 510(K)
- K153033Digital Blood Pressure Monitor2Cleared 510(K)
- K161156Full Automatic (NIBP) Blood Pressure Monitor2Cleared 510(K)
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform2Cleared 510(K)
- K153552AGE Automatic Upper Arm Blood Pressure Monitor2Cleared 510(K)
- K152415Digital Blood Pressure Monitor2Cleared 510(K)
- K160019U80 Series Upper Arm Electronic Blood Pressure Monitor2Cleared 510(K)
- K151953A&D Medical TM-2657 Family of Digital Blood Pressure Monitors2Cleared 510(K)
- K152107HealthChek Network Health Station2Cleared 510(K)
- K160336Full Automatic (NIBP) Blood Pressure Monitor2Cleared 510(K)
- K151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor2Cleared 510(K)
- K160145Full Automatic (NIBP) Blood Pressure Monitor2Cleared 510(K)
- K152831Spot Skan2Cleared 510(K)
- K151520Oscar 22Cleared 510(K)
- K151258Arm automatic blood pressure monitor2Cleared 510(K)
- K153077Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K160014iHealth Track Blood Pressure Monitor2Cleared 510(K)
- K153214Full Automatic (NIBP) Blood Pressure Monitor2Cleared 510(K)
- K153450Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K150908XM-01 Electronic Automatic Blood Pressure Monitor2Cleared 510(K)
- K151127higi Station2Cleared 510(K)
- K152426Wrist - Type Fully Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K152770ProBP 2400 Digital Blood Pressure Device2Cleared 510(K)
- K151415Oregon Scientific2Cleared 510(K)
- K152687Arm-Type Fully Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K152483Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series2Cleared 510(K)
- K152003iHealth BP3L Wireless Blood Pressure Monitor2Cleared 510(K)
- K152379iHealth View BP7S Wireless Blood Pressure Wrist Monitor2Cleared 510(K)
- K151460Fully Automatic Electronic Blood Pressure Monitor2Cleared 510(K)
- K151869Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K150311Full Automatic (NIBP)Blood Pressure Monitor2Cleared 510(K)
- K151583Digital Automatic Wrist Blood Pressure Monitor MD39002Cleared 510(K)
- K151587Digital Automatic Wrist Blood Pressure Monitor MD32002Cleared 510(K)
- K143735Digital Automatic Blood Pressure Monitor MD23002Cleared 510(K)
- K151330Microlife Wrist Watch Blood Pressure Monitor2Cleared 510(K)
- K140762AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K151281AGE Automatic Wrist Blood Pressure Monitor2Cleared 510(K)
- K150373Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]2Cleared 510(K)
- K143734Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD28102Cleared 510(K)
- K141984FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K143341Microlife Upper Arm Automatic Digital Blood Pressure Monitor2Cleared 510(K)
- K150430Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor2Cleared 510(K)
- K140360HEALTH KIOSK2Cleared 510(K)
- K143733Digital Automatic Wrist Blood Pressure Monitor MD24002Cleared 510(K)
- K141683ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K150545Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)2Cleared 510(K)
- K143108HealthGuard-152Cleared 510(K)
- K141460FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR2Cleared 510(K)
- K142968Full Automatic (NIBP) Blood Pressure Monitor2Cleared 510(K)
- K142917BP652N (HEM-6300-Z)2Cleared 510(K)
- K133989AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K141755ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K142088DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES2Cleared 510(K)
- K141416BLOOD PRESSURE MONITOR2Cleared 510(K)
- K141201A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K141160A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K141113SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE2Cleared 510(K)
- K140928ABPM71002Cleared 510(K)
- K141924HD BLOOD PRESSURE MONITOR2Cleared 510(K)
- K141083MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR2Cleared 510(K)
- K134029BELTER BLOOD PRESSURE METER2Cleared 510(K)
- K140572MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K140121FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K141179A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K140583DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES2Cleared 510(K)
- K140067QARDIOARM2Cleared 510(K)
- K140312EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM2Cleared 510(K)
- K140412ANS1 SOFTWARE2Cleared 510(K)
- K133588FORA CARE BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K133125WITHINGS BLOOD PRESURE MONITOR2Cleared 510(K)
- K131916BPROSOFT CASP PC SOFTWARE2Cleared 510(K)
- K133618DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES2Cleared 510(K)
- K133619DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES2Cleared 510(K)
- K133383HEM-73202Cleared 510(K)
- K131788HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE2Cleared 510(K)
- K131245OREGON SCINTIFIC2Cleared 510(K)
- K133379HEM-73112Cleared 510(K)
- K130325ARM AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K132240DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES2Cleared 510(K)
- K131026BOSCH BLOOD PRESSURE METER (BP5000 BT)2Cleared 510(K)
- K132627AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K131749HEM-62212Cleared 510(K)
- K130232ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM2Cleared 510(K)
- K123130ANSWATCH WRIST MONITOR MODEL TS-04112Cleared 510(K)
- K130925AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K131064BIOSPACE2Cleared 510(K)
- K131558PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B62Cleared 510(K)
- K123882AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR2Cleared 510(K)
- K131742HEM-61312Cleared 510(K)
- K131203IHEALTH CLOUD2Cleared 510(K)
- K131463WRIST AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K131395TRANSTEK BLOOD PRESSURE MONITOR2Cleared 510(K)
- K130564FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR2Cleared 510(K)
- K130563FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR2Cleared 510(K)
- K131569PG-800A SERIES2Cleared 510(K)
- K131346MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K131121FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR2Cleared 510(K)
- K123800WRIST AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K122013MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)2Cleared 510(K)
- K123600DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K123539STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK2Cleared 510(K)
- K122381NEXFIN MODEL 22Cleared 510(K)
- K122076PERSONAL HEALTH CENTER (PHC)2Cleared 510(K)
- K123498BP652N (HEM-6300-Z)2Cleared 510(K)
- K122098APPS-HEALTH012Cleared 510(K)
- K123073DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X02Cleared 510(K)
- K123780TRANSTEK BLOOD PRESSURE MONITOR2Cleared 510(K)
- K120673DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES2Cleared 510(K)
- K120675DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES2Cleared 510(K)
- K122810COMPACT DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K123839WA SERIES: WA100; WA200; WD100; WE100, WF100; WB2002Cleared 510(K)
- K123669TRANSTEK WRIST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K121266CARDIOSCOPE2Cleared 510(K)
- K123446TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K123020BLIP MODEL BP-700WF2Cleared 510(K)
- K122443UFIT TEN-102Cleared 510(K)
- K122129SPHYGMOCOR XCEL2Cleared 510(K)
- K122401TANGO M2 BLOOD PRESSURE MONITOR2Cleared 510(K)
- K120545HX-4612Cleared 510(K)
- K122482TRANSTEK WRIST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K121372FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K121932HEM-7200-Z (BP742)2Cleared 510(K)
- K121025YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION2Cleared 510(K)
- K120320CONNECTED CARE CLINICAL APPLICATION2Cleared 510(K)
- K120554ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K120430MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P2Cleared 510(K)
- K112620DISITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K121355WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K120634U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K121470FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR2Cleared 510(K)
- K120672KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR2Cleared 510(K)
- K113402SOLOHEALTH STATION2Cleared 510(K)
- K121141TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K113239FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)2Cleared 510(K)
- K113264ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)2Cleared 510(K)
- K113238FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR2Cleared 510(K)
- K112691BLOOD PRESSURE MONITOR2Cleared 510(K)
- K112690BLOOD PRESSURE MONITOR2Cleared 510(K)
- K111141BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K120144VITAL SIGNS MONITOR2Cleared 510(K)
- K120132SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR2Cleared 510(K)
- K112042KINGYIELD WRIST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K120058TRANSTEK BLOOD PRESSURE MONITOR2Cleared 510(K)
- K113185MODEL HBP-13002Cleared 510(K)
- K113083TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR2Cleared 510(K)
- K112825AVITA ARM TYPE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K113085TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K112216U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K112521FUKUDA DENSHI VASERA MODEL VS-15002Cleared 510(K)
- K112274U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K110603HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)2Cleared 510(K)
- K111830FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO2Cleared 510(K)
- K111826FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K112845MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K112647BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K112273ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K112270ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K110770HEALTHTRACKER2Cleared 510(K)
- K103058MULTIFUNCTION KEITO2Cleared 510(K)
- K112269OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE2Cleared 510(K)
- K112652SURESIGNS VS2+ -SURESIGNS VSI2Cleared 510(K)
- K112320FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR2Cleared 510(K)
- K111686A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS2Cleared 510(K)
- K110156AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,2Cleared 510(K)
- K111652MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR2Cleared 510(K)
- K110044FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K101681TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-9952Cleared 510(K)
- K111114SURESIGNS VS2 VITAL SIGNS MONITOR2Cleared 510(K)
- K110872WITHINGS BLOOD PRESSURE MONITOR2Cleared 510(K)
- K110803SURESIGNS VSI VITAL SIGNS MONITOR2Cleared 510(K)
- K110774ELECTRONIC SPHYGMOMANOMETER2Cleared 510(K)
- K110775ELECTRONIC SPHYGMOMANOMETER2Cleared 510(K)
- K110501HEM-40302Cleared 510(K)
- K110299DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES2Cleared 510(K)
- K110018FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K102939FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-9312Cleared 510(K)
- K110330FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K102968INFINITY CNAP SMARTPOD2Cleared 510(K)
- K103693VANTAGE ABI2Cleared 510(K)
- K103732SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR2Cleared 510(K)
- K103046HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE2Cleared 510(K)
- K102624AVITA WRIST TYPE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K102609KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K102690FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K102988ELECTRONIC BLOOD PRESURE MONITOR2Cleared 510(K)
- K102631KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K102930FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K102906FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K101123NEXFIN MODEL 22Cleared 510(K)
- K102920ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K102356FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-5342Cleared 510(K)
- K102353FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5132Cleared 510(K)
- K102303BLOOD PRESSURE METER, MODEL CH-6582Cleared 510(K)
- K101950FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-9302Cleared 510(K)
- K100055BLOOD PRESSURE METER, MODEL CH-6092Cleared 510(K)
- K100763MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-42Cleared 510(K)
- K101198CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K2Cleared 510(K)
- K101010FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-50082Cleared 510(K)
- K093981YRNSORTIP OXIMANOMETER2Cleared 510(K)
- K101680WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES2Cleared 510(K)
- K100658U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K100620FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-5502Cleared 510(K)
- K101512MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4).2Cleared 510(K)
- K100940FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-59652Cleared 510(K)
- K093931BLOOD PRESSURE METER, MODEL CH-45322Cleared 510(K)
- K101002A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T72002Cleared 510(K)
- K093102AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-2702Cleared 510(K)
- K101275MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS).2Cleared 510(K)
- K100913IQVITALS AND IQVITALS SYSTEM2Cleared 510(K)
- K100553BLOOD PRESSURE METER MODEL CH-1012Cleared 510(K)
- K093739BLOOD PRESSURE MONITOR/ MODELS2Cleared 510(K)
- K093907WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE2Cleared 510(K)
- K093802ULTRAVIEW DM3 MONITOR2Cleared 510(K)
- K093205PADCHECK2Cleared 510(K)
- K092061FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-02172Cleared 510(K)
- K093831FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT2Cleared 510(K)
- K092558WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES2Cleared 510(K)
- K093824FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT2Cleared 510(K)
- K100014FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5572Cleared 510(K)
- K092106U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-31322Cleared 510(K)
- K093823FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM2Cleared 510(K)
- K092893TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES2Cleared 510(K)
- K092811FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-79032Cleared 510(K)
- K093013BLOOD PRESSURE MONITOR, MODEL MD200A2Cleared 510(K)
- K092588FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-59182Cleared 510(K)
- K093452FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-79712Cleared 510(K)
- K092510FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-79112Cleared 510(K)
- K093528FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-79632Cleared 510(K)
- K092514UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES2Cleared 510(K)
- K093387FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-59022Cleared 510(K)
- K0933591103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 11332Cleared 510(K)
- K093389CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK2Cleared 510(K)
- K092163FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB2Cleared 510(K)
- K092456MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C2Cleared 510(K)
- K091414VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH2Cleared 510(K)
- K092806AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-77702Cleared 510(K)
- K092432AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)2Cleared 510(K)
- K092161FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF2Cleared 510(K)
- K092683DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 11432Cleared 510(K)
- K091553BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE2Cleared 510(K)
- K092719DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K091434TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M2Cleared 510(K)
- K091415TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M2Cleared 510(K)
- K091897BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-30192Cleared 510(K)
- K091821COMMANDER 111, MODEL CD300-CD3992Cleared 510(K)
- K091738SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD2Cleared 510(K)
- K091737FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-50312Cleared 510(K)
- K091739SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 39092Cleared 510(K)
- K091500MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5562Cleared 510(K)
- K092045FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-7392Cleared 510(K)
- K091997FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-79622Cleared 510(K)
- K083753SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU2Cleared 510(K)
- K090772FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-59092Cleared 510(K)
- K090770FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-59052Cleared 510(K)
- K090769FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-79612Cleared 510(K)
- K090768FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909,2Cleared 510(K)
- K090771FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-59622Cleared 510(K)
- K091068ACCUTORR V MONITOR, MODEL 0998-00-20002Cleared 510(K)
- K090963FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5562Cleared 510(K)
- K090058YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB2Cleared 510(K)
- K083395SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-5982Cleared 510(K)
- K090027BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/1072Cleared 510(K)
- K083319FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-79412Cleared 510(K)
- K083318FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-59042Cleared 510(K)
- K083317FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-59022Cleared 510(K)
- K083247FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-79062Cleared 510(K)
- K083246FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-59612Cleared 510(K)
- K083248FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-79022Cleared 510(K)
- K083681BIOLAND BLOOD PRESSURE MONITOR2Cleared 510(K)
- K081924CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE2Cleared 510(K)
- K081498TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 2052Cleared 510(K)
- K081852TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB112Cleared 510(K)
- K083078QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH2002Cleared 510(K)
- K082881MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O32Cleared 510(K)
- K082734A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K082357MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).2Cleared 510(K)
- K083043KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP2012Cleared 510(K)
- K082599NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT2Cleared 510(K)
- K081654HEM-9000AI2Cleared 510(K)
- K081159HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES2Cleared 510(K)
- K080326KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K072109STATMAP, MODEL 72002Cleared 510(K)
- K080319KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K081590YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J2Cleared 510(K)
- K080337MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D2Cleared 510(K)
- K080177WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV2Cleared 510(K)
- K080274AMBULO 24002Cleared 510(K)
- K080789BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-2022Cleared 510(K)
- K073445CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-30262Cleared 510(K)
- K0802891500 PRO2Cleared 510(K)
- K072860YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-5002Cleared 510(K)
- K073630MODIFICATION TO: BPCARD, MODEL Z-7000-07002Cleared 510(K)
- K073198MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)2Cleared 510(K)
- K073397MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)2Cleared 510(K)
- K073398MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)2Cleared 510(K)
- K072137AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB2Cleared 510(K)
- K072446MOBIL-O-GRAPH NG 24 H ABP-CONTROL2Cleared 510(K)
- K072049CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS2Cleared 510(K)
- K072593A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE2Cleared 510(K)
- K071384MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 19012Cleared 510(K)
- K072272HONEYWELL HOMMED CENTRAL STATION 4.02Cleared 510(K)
- K070826KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K070828KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K062974TESLA NIBP2Cleared 510(K)
- K070209FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K071960MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-052Cleared 510(K)
- K071523FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP17502Cleared 510(K)
- K070395KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K063008HEALTH CHECK KIOSK2Cleared 510(K)
- K071075TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A2Cleared 510(K)
- K070825LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K070473BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX2Cleared 510(K)
- K070086SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K070750247 BP DEVICE2Cleared 510(K)
- K063137PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-20002Cleared 510(K)
- K062033BP 101 DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K063814BP-200 PLUS2Cleared 510(K)
- K062893KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A2Cleared 510(K)
- K063111FINOMETER MODEL-2 WITH ACCESSORIES2Cleared 510(K)
- K062027A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K061935SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K062462NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L2Cleared 510(K)
- K061557FUSION2Cleared 510(K)
- K061471MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC2Cleared 510(K)
- K061959MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 1803102Cleared 510(K)
- K061279LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K061760ARM BLOOD PRESSURE MONITOR, MODEL KP-76002Cleared 510(K)
- K061086DM-3000 DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K061822OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N32Cleared 510(K)
- K061452TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM2Cleared 510(K)
- K061558MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U2Cleared 510(K)
- K061161BLOOD PRESSURE METER, MODEL CH-311B2Cleared 510(K)
- K061456A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K061403MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U2Cleared 510(K)
- K060686MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC2Cleared 510(K)
- K060820CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 10602Cleared 510(K)
- K061073CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-32502Cleared 510(K)
- K060925ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-1122Cleared 510(K)
- K053453HOMMED CENTRAL STATION, VERSION 3.52Cleared 510(K)
- K060835HL888SF2Cleared 510(K)
- K060729FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV2Cleared 510(K)
- K060315HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K060703PMP4 BP PRO BLOOD PRESSURE MONITOR2Cleared 510(K)
- K060342ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K2Cleared 510(K)
- K060504IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 00012Cleared 510(K)
- K060077RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A2Cleared 510(K)
- K052450KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K052676KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K060194MARCH HEALTHCARE HEALTH MONITORING KIT2Cleared 510(K)
- K052671HOCA EZ-CARE BP108, TENDER-CARE BP1092Cleared 510(K)
- K053185PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM2Cleared 510(K)
- K053209TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM2Cleared 510(K)
- K051847KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K053303CARDIOCOM COMMANDER III2Cleared 510(K)
- K053304COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM2Cleared 510(K)
- K051903FETALGARD LITE-NIBP, MODEL FGL-NIBP2Cleared 510(K)
- K053395BP PRO BLOOD PRESSURE MONITOR2Cleared 510(K)
- K052727ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K3502Cleared 510(K)
- K052872IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A2Cleared 510(K)
- K052784DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-9002Cleared 510(K)
- K051149MEDITECH MODEL ABPM-042Cleared 510(K)
- K050233OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI2Cleared 510(K)
- K052046BLOOD PRESSURE METER, MODEL CH-4322Cleared 510(K)
- K051366PICONIBP OEM MODULE2Cleared 510(K)
- K051565PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA2Cleared 510(K)
- K052154OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC2Cleared 510(K)
- K052153OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL2Cleared 510(K)
- K051862PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.2Cleared 510(K)
- K051863AMLUCK, YA HORNG2Cleared 510(K)
- K051703CLEVER TD-3018A BLOOD PRESSURE MONITOR2Cleared 510(K)
- K051368BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM2Cleared 510(K)
- K051375VITAL SIGNS MONITOR2Cleared 510(K)
- K051106THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS2Cleared 510(K)
- K051546BPCALIBRATOR MC3000/MC31002Cleared 510(K)
- K050680BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K72Cleared 510(K)
- K043531MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-68222Cleared 510(K)
- K050083BLOOD-PRESSURE METER, BPW1202Cleared 510(K)
- K050711FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT2Cleared 510(K)
- K050714FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS2Cleared 510(K)
- K050587FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM2Cleared 510(K)
- K042505OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N2Cleared 510(K)
- K042506OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M2Cleared 510(K)
- K050491H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF2Cleared 510(K)
- K043352GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR2Cleared 510(K)
- K050249HL168JP2Cleared 510(K)
- K050040MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR2Cleared 510(K)
- K050697MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K050039MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR2Cleared 510(K)
- K042418KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K042109DIASYS INTEGRA II2Cleared 510(K)
- K050413AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M6002Cleared 510(K)
- K043217A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K042768MEDICOMPASS CONNECT2Cleared 510(K)
- K043550AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M1002Cleared 510(K)
- K042818PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW30372Cleared 510(K)
- K043437FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET2Cleared 510(K)
- K032825VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR2Cleared 510(K)
- K043186H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM2Cleared 510(K)
- K042967A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-5122Cleared 510(K)
- K041693WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES2Cleared 510(K)
- K043096COMMANDER II2Cleared 510(K)
- K043018OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-9062Cleared 510(K)
- K042853FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA2Cleared 510(K)
- K042802H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q2Cleared 510(K)
- K042581AMLUCK, YA HORNG2Cleared 510(K)
- K041854MPM SYSTEM2Cleared 510(K)
- K041491ZEWA MFM-007 BLOOD PRESSURE MONITOR2Cleared 510(K)
- K042273MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY2Cleared 510(K)
- K042265FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL8882Cleared 510(K)
- K041778REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T2Cleared 510(K)
- K040562LIFECLINIC, MODEL 24002Cleared 510(K)
- K042138FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-3112Cleared 510(K)
- K041400FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-012Cleared 510(K)
- K041169PIESOMETER, MODEL MK-12Cleared 510(K)
- K040799HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS2Cleared 510(K)
- K040490WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE2Cleared 510(K)
- K040651HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM2Cleared 510(K)
- K042014DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-94002Cleared 510(K)
- K041411MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP2Cleared 510(K)
- K041789NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T2Cleared 510(K)
- K041313STABIL-O-GRAPH2Cleared 510(K)
- K040371A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K041228MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-2002Cleared 510(K)
- K031327VERICOR2Cleared 510(K)
- K032927FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K040410GREENLIGHT 3002Cleared 510(K)
- K033216BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K040528AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T2Cleared 510(K)
- K033397AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY2Cleared 510(K)
- K040012WELL@HOME SYSTEM2Cleared 510(K)
- K040159APM BLOOD PRESSURE MONITOR, MODEL BP108A2Cleared 510(K)
- K040002MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX12Cleared 510(K)
- K031487MODEL AVANT 2120 PULSE OXIMETER AND NIBP2Cleared 510(K)
- K040229A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-3282Cleared 510(K)
- K033894PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 30322Cleared 510(K)
- K040086HEALTH BUDDY WITH BUDDYLINK2Cleared 510(K)
- K040032CENTRAL STATION, VERSION 3.3H2Cleared 510(K)
- K040309DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-18622Cleared 510(K)
- K032305OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL2Cleared 510(K)
- K032857PRESS-MATE BX-10 VITAL SIGN MONITOR2Cleared 510(K)
- K033025TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 7002Cleared 510(K)
- K032308BLOOD PRESSURE MONITOR, MODEL M1002Cleared 510(K)
- K030359KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K032363ZOLL M SERIES NIBP OPTION2Cleared 510(K)
- K030358KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K032499A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS2Cleared 510(K)
- K023723FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 12Cleared 510(K)
- K033043MODIFICATION TO HL1682Cleared 510(K)
- K032837HL888BM2Cleared 510(K)
- K032839HL888BA2Cleared 510(K)
- K031840CAREMATIX WELLNESS SYSTEM2Cleared 510(K)
- K032695HL888BF2Cleared 510(K)
- K032913HL888 AF2Cleared 510(K)
- K032492BLOOD PRESSURE MONITOR, MODEL KP-70002Cleared 510(K)
- K031964BPCARD2Cleared 510(K)
- K030221MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K031695HL168R2Cleared 510(K)
- K031835HL888RA2Cleared 510(K)
- K031479AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 925062Cleared 510(K)
- K022926GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-1002Cleared 510(K)
- K030230AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)2Cleared 510(K)
- K030561MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A2Cleared 510(K)
- K023338PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-22Cleared 510(K)
- K023286CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION2Cleared 510(K)
- K030541HL888JF2Cleared 510(K)
- K030499HL888HM2Cleared 510(K)
- K030498HL888HA2Cleared 510(K)
- K030825MPM-NET2Cleared 510(K)
- K023078BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR2Cleared 510(K)
- K024077DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR2Cleared 510(K)
- K024005WELCH ALLYN VITAL SIGN MONITOR WITH MP5062Cleared 510(K)
- K023834HL8882Cleared 510(K)
- K021682OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC2Cleared 510(K)
- K022916BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-62112Cleared 510(K)
- K022783TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K021239EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M2Cleared 510(K)
- K021240EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-2002Cleared 510(K)
- K023495WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)2Cleared 510(K)
- K023055BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-2002Cleared 510(K)
- K014141DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D112Cleared 510(K)
- K020537TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K020897ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q4002Cleared 510(K)
- K013434VP-2000/10002Cleared 510(K)
- K021305MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER2Cleared 510(K)
- K021756WELCH ALLYN ABPM 61002Cleared 510(K)
- K021252BLOOD-PRESSURE METER2Cleared 510(K)
- K021447TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM2Cleared 510(K)
- K021225ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I2Cleared 510(K)
- K020584N2000 BASE STATION; N2001 NURSE STATION2Cleared 510(K)
- K020184HOMMED CENTRAL STATION2Cleared 510(K)
- K021029ABP-2000 G-32Cleared 510(K)
- K020766HL168F2Cleared 510(K)
- K012796AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-40002Cleared 510(K)
- K014204ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-68222Cleared 510(K)
- K012487SPHYGMOCOR PX MODEL SCOR-PX2Cleared 510(K)
- K012472A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS2Cleared 510(K)
- K011625VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)2Cleared 510(K)
- K013583ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS2Cleared 510(K)
- K013539ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS2Cleared 510(K)
- K013485MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA12Cleared 510(K)
- K014122HL168E2Cleared 510(K)
- K013478DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K013358DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K012801N2000 BASE STATION, N2001 NURSE STATION2Cleared 510(K)
- K012647TONOPORT V2Cleared 510(K)
- K012498DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K012636BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-1002Cleared 510(K)
- K013033MODIFICATION TO: HL168W TOUCH SCREEN2Cleared 510(K)
- K011058TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII2Cleared 510(K)
- K012310MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR2Cleared 510(K)
- K012054FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-3122Cleared 510(K)
- K012035BRAUN PRECISION SENSOR PRO, MODEL BP 25902Cleared 510(K)
- K011539ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS2Cleared 510(K)
- K011352ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS2Cleared 510(K)
- K011310NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-12Cleared 510(K)
- K012013LIFESOURCE MODELS UA-787, UA 787PC, UA-787T2Cleared 510(K)
- K011779AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM2Cleared 510(K)
- K010029HOME HEALTH MONITORING SYSTEM2Cleared 510(K)
- K003180HOMMED OBSERVER, MODEL I2Cleared 510(K)
- K011523ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW1382Cleared 510(K)
- K010751BPFONE, MODEL UA 767IT2Cleared 510(K)
- K010186WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM2Cleared 510(K)
- K011152VASOTRAC APM205A2Cleared 510(K)
- K003732BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES2Cleared 510(K)
- K010828DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP2Cleared 510(K)
- K010622PRESSURE TRAK, MODEL 222-B2Cleared 510(K)
- K010498WRISTWATCH BLOOD PRESSURE MONITOR A462Cleared 510(K)
- K002665WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-61202Cleared 510(K)
- K010190WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A432Cleared 510(K)
- K002791NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM2Cleared 510(K)
- K001543BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 525202Cleared 510(K)
- K003711AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P2Cleared 510(K)
- K003444MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K002530WELCH ALLYN SPOT CHECK DEVICE2Cleared 510(K)
- K003282FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H2Cleared 510(K)
- K001948CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM2Cleared 510(K)
- K003004OSCAR 2, MODEL 2222Cleared 510(K)
- K002882HL168B2Cleared 510(K)
- K001244BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D2Cleared 510(K)
- K002248DINAMAP PRO 1000 MONITOR, MODEL 10002Cleared 510(K)
- K002029ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION2Cleared 510(K)
- K002750HL168T2Cleared 510(K)
- K002722DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-5052Cleared 510(K)
- K002655DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-5502Cleared 510(K)
- K001898VASOTRAX2Cleared 510(K)
- K002388EHC500 DESKTOP PATIENT STATION, MODEL EHC5002Cleared 510(K)
- K001182MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU12Cleared 510(K)
- K002115A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS2Cleared 510(K)
- K002046MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-1002Cleared 510(K)
- K001848OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-9072Cleared 510(K)
- K001671ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-6302Cleared 510(K)
- K001670AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-7572Cleared 510(K)
- K000237EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION2Cleared 510(K)
- K993316UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE2Cleared 510(K)
- K000500DINAMAP ADVANCED NIBP MODULE2Cleared 510(K)
- K991458MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW2542Cleared 510(K)
- K994423AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-1002Cleared 510(K)
- K993938THE HOMMED SENTRY, MODEL 1 SENTRY2Cleared 510(K)
- K000675MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-5022Cleared 510(K)
- K984083MULTIFUNCTION KEITO K52Cleared 510(K)
- K993460ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z432Cleared 510(K)
- K993429ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z402Cleared 510(K)
- K993426ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z442Cleared 510(K)
- K993542ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V462Cleared 510(K)
- K993888A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS2Cleared 510(K)
- K993432ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z462Cleared 510(K)
- K990807HL148 & HL1682Cleared 510(K)
- K993890DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1812Cleared 510(K)
- K992478PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A2Cleared 510(K)
- K983616DAIWA MODEL 1802Cleared 510(K)
- K990638ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K983717BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM2Cleared 510(K)
- K992808A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE2Cleared 510(K)
- K990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM2Cleared 510(K)
- K990648KELLER VITAL SIGNS MONITOR, KMS 890+2Cleared 510(K)
- K992328FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-8002Cleared 510(K)
- K991688WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S2Cleared 510(K)
- K983575ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX2Cleared 510(K)
- K984223BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-4712Cleared 510(K)
- K982641ADVANCED NIBP MODULE2Cleared 510(K)
- K984618BCI MINI-TORR PLUS, MODEL 60042Cleared 510(K)
- K981702AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-3002Cleared 510(K)
- K981542PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW2842Cleared 510(K)
- K981431PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW2802Cleared 510(K)
- K964235ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL2Cleared 510(K)
- K990380(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-7002Cleared 510(K)
- K9837966004 NIBP MONITOR WITH TEMPERATURE2Cleared 510(K)
- K980845MS-900S, MS-900SPM & MS-900SFM2Cleared 510(K)
- K983855FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F2Cleared 510(K)
- K982481A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K973637PRESS-MATE ADVANTAGE2Cleared 510(K)
- K982135OSCILLOMATE EMS NIBP MONITOR MODEL 90012Cleared 510(K)
- K964153ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-40002Cleared 510(K)
- K973613CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER2Cleared 510(K)
- K980824A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K973061CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)2Cleared 510(K)
- K972795CARDIO-CARD MANAGEMENT SYSTEM II2Cleared 510(K)
- K974061RECHARGEABLE BATTERY PART NUMBER GL825-2002Cleared 510(K)
- K970629TANGO NON-INVASIVE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K970801BCI MODEL 6004 NIBP MONITOR (6004)2Cleared 510(K)
- K954547CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER2Cleared 510(K)
- K961144MS-20002Cleared 510(K)
- K964697AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION2Cleared 510(K)
- K952827FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-50002Cleared 510(K)
- K952826FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-70002Cleared 510(K)
- K952882PERSONAL TELEMEDICINE SYSTEM2Cleared 510(K)
- K952979HANC NETWORK2Cleared 510(K)
- K960319A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K955342OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER2Cleared 510(K)
- K951193CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E12Cleared 510(K)
- K945215MARS DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K952494DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K945138OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS2Cleared 510(K)
- K951977DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM8832Cleared 510(K)
- K953472NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR2Cleared 510(K)
- K942543ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS2Cleared 510(K)
- K945111DYNAPULSE 5000A (DP5000A)2Cleared 510(K)
- K942072MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND2Cleared 510(K)
- K945947NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER2Cleared 510(K)
- K942422PANASONIC WRIST BLOOD PRESSURE METER2Cleared 510(K)
- K942423NAIS WRIST BLOOD PRESSURE METER2Cleared 510(K)
- K950249VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 2052Cleared 510(K)
- K943081TRIMLINE 20002Cleared 510(K)
- K942546CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER2Cleared 510(K)
- K942163WINNER SELF-TAKING HOME BLOOD PRESSURE KIT2Cleared 510(K)
- K942649MINIMUS I; MINIMUS III, SANAPHON2Cleared 510(K)
- K941490BLOOD PRESSURE METER MODEL NO. BPM8882Cleared 510(K)
- K942336AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K941167NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)2Cleared 510(K)
- K942871PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM2Cleared 510(K)
- K942650BIG BEN2Cleared 510(K)
- K934385MINIPACK 3100/3000 MODIFICATION2Cleared 510(K)
- K940620ROSSMAX INTERNATIONAL LIMITED ACCURACY BLOOD PRESSURE MONITOR2Cleared 510(K)
- K935782DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES2Cleared 510(K)
- K943461VARIOUS TYPES OF MERCURIALS2Cleared 510(K)
- K925295EXACTA-SPEZIAL2Cleared 510(K)
- K925294PRECISA2Cleared 510(K)
- K932823BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK2Cleared 510(K)
- K935872NAMTAI2Cleared 510(K)
- K935652NAMTAI2Cleared 510(K)
- K932109PROFILOMAT2Cleared 510(K)
- K923344ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K925402OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 93002Cleared 510(K)
- K923595SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K921048BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST2Cleared 510(K)
- K915697CRITIKON VITAL SIGNS MODULE2Cleared 510(K)
- K930798OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.2Cleared 510(K)
- K924910SYSTEM 7500 NIBP/SA022Cleared 510(K)
- K920778OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-6012Cleared 510(K)
- K914823OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-7062Cleared 510(K)
- K924210NAMTAI ELECTRONIC BLOOD PRESSURE METER2Cleared 510(K)
- K914765SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS2Cleared 510(K)
- K921627DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-1012Cleared 510(K)
- K921074BP PUMP2Cleared 510(K)
- K912815NIBP 9225 COMBI2Cleared 510(K)
- K915468MODEL P-81 CRITIKON PRINTER2Cleared 510(K)
- K9142604240 DYNAMIC BP/HEART RATE MONITOR2Cleared 510(K)
- K913844ACCUTRACKER DX2Cleared 510(K)
- K913595DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K911645NGM NIBP MODULE2Cleared 510(K)
- K911722OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 16302Cleared 510(K)
- K912588AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS2Cleared 510(K)
- K911871CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS2Cleared 510(K)
- K913523AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR2Cleared 510(K)
- K911965ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR2Cleared 510(K)
- K910643CASIO BP-1002Cleared 510(K)
- K912530CARDIOCAP II(TM)2Cleared 510(K)
- K911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP2Cleared 510(K)
- K912118DIGITAL SPHYGMOMANOMETER MODEL UA-8332Cleared 510(K)
- K912119DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 2122Cleared 510(K)
- K911049DIGITAL SPHYGMOIMANOMETER, MODEL UA-8302Cleared 510(K)
- K903237CARDIOCAP CMX-104 MONITOR2Cleared 510(K)
- K904298EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K911310COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD2Cleared 510(K)
- K910772PROPAQ 102, 104 AND 1062Cleared 510(K)
- K905367E-20 RAPID CUFF INFLATOR2Cleared 510(K)
- K903771HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE2Cleared 510(K)
- K903133OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C2Cleared 510(K)
- K904739DYNAPULSE 200M2Cleared 510(K)
- K903134OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C2Cleared 510(K)
- K904318LOCAL REPORT GENERATOR2Cleared 510(K)
- K897173SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K903222BIOCHEM 6100 NON-INVASIVE MONITOR2Cleared 510(K)
- K901392BP50 BLOOD PRESSURE AND PULSE MONITOR2Cleared 510(K)
- K901889FUKUDA DENSHI MODEL HJ-3102Cleared 510(K)
- K900247CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM2Cleared 510(K)
- K896958ESCORT NON-INVASIVE BLOOD PRESSURE OPTION2Cleared 510(K)
- K894563OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F2Cleared 510(K)
- K896633AUTO-CUFF(TM)2Cleared 510(K)
- K882955SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 72832Cleared 510(K)
- K896102MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR2Cleared 510(K)
- K895428A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/202Cleared 510(K)
- K895429A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 26502Cleared 510(K)
- K894945NON-INVASIVE BLOOD PRESSURE MODULE2Cleared 510(K)
- K894693AP-851PA NIBP MODULE2Cleared 510(K)
- K894062ELECTRONIC BLOOD PRESSURE MONITORS2Cleared 510(K)
- K890198PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350)2Cleared 510(K)
- K885191MRL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K884405FORTEC MI-150 DIGITAL BLOOD PRESSURE METER2Cleared 510(K)
- K890005TYPE 9225 NIBP2Cleared 510(K)
- K884885BP-408 MARK II2Cleared 510(K)
- K884742ESCORT NON-INVASIVE BLOOD PRESSURE OPTION2Cleared 510(K)
- K882825TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN2Cleared 510(K)
- K882824TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR2Cleared 510(K)
- K881771SENSOCOR(TM) DIASYS2Cleared 510(K)
- K884955CARDIOCAP(TM) CM-104 MONITOR2Cleared 510(K)
- K882635ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K880599POCKET MANOMETER2Cleared 510(K)
- K882393DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP2Cleared 510(K)
- K882188MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR2Cleared 510(K)
- K881155MODEL BPS08 BLOOD PRESSURE MODULE2Cleared 510(K)
- K881272ACCUSTAT MODEL 102 NON-INVASIVE BLOOD MONITORING2Cleared 510(K)
- K881269OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C2Cleared 510(K)
- K881602OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C2Cleared 510(K)
- K881601OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C2Cleared 510(K)
- K873764AMBULATORY BLOOD PRESSURE MONITOR2Cleared 510(K)
- K881003DIGITAL BLOOD PRESSURE MONITOR MODEL CX-12Cleared 510(K)
- K880572OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR2Cleared 510(K)
- K874917PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K880715(MB-650) BLOOD PRESSURE MONITOR2Cleared 510(K)
- K880351VITAL SYSTEM2Cleared 510(K)
- K875265NON-INVASIVE BLOOD PRESSURE MODULE2Cleared 510(K)
- K875093NEW MODEL MB-550 BLOOD PRESSURE MONITOR2Cleared 510(K)
- K874378DINAMAP VITAL SIGNS MONITOR, MODEL 8100T2Cleared 510(K)
- K873979DYNAMARK 10002Cleared 510(K)
- K872629TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-7412Cleared 510(K)
- K872355COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 4702Cleared 510(K)
- K871886MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT2Cleared 510(K)
- K871418VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)2Cleared 510(K)
- K861374SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 72822Cleared 510(K)
- K864411PULSE/B.P. MONITOR2Cleared 510(K)
- K871794EASY READ(TM)2Cleared 510(K)
- K871719MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER2Cleared 510(K)
- K871482HYPERTENSION RISK DETECTOR(TM)2Cleared 510(K)
- K871363MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE2Cleared 510(K)
- K870460DORROS(TM) SMALL VESSEL PTA CATHETER2Cleared 510(K)
- K871207OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C2Cleared 510(K)
- K870049EMT-102 CARDIAC MONITOR2Cleared 510(K)
- K862427MODIFIED DRAGER SPHYGMOMED2Cleared 510(K)
- K864318THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM2Cleared 510(K)
- K864737NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 3402Cleared 510(K)
- K863891MODIFIED STBP-6802Cleared 510(K)
- K864654COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K8619872120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF2Cleared 510(K)
- K861856NBP 488, TPR 4882Cleared 510(K)
- K864666MODIFIED LIFESTAT 2002Cleared 510(K)
- K864665MODIFIED VSM 2 VITAL SIGNS MONITOR2Cleared 510(K)
- K863672MODEL (MB-700) BLOOD PRESSURE MONITOR2Cleared 510(K)
- K855048NORELCO DIGITAL BLOOD PRESSURE METER HC30012Cleared 510(K)
- K854279NORELCO ELECTRONIC DIGITAL BP METER HC30302Cleared 510(K)
- K855177NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER2Cleared 510(K)
- K861504MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K860488OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9152Cleared 510(K)
- K855127AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #902022Cleared 510(K)
- K862756PREGELLED INFANT DISPOSABLE ECG ELECTRODE2Cleared 510(K)
- K861364NEOGUARD ECG ELECTRODES2Cleared 510(K)
- K861375MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS2Cleared 510(K)
- K860634PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP2Cleared 510(K)
- K854481COLIN ELECTRONICS CO., LTD. STBP 6802Cleared 510(K)
- K853561LIFESTAT 1002Cleared 510(K)
- K854942HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.2Cleared 510(K)
- K854434DINAMAP VITAL SIGNS MONITOR MODEL 81002Cleared 510(K)
- K860196OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 9012Cleared 510(K)
- K854797TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-7312Cleared 510(K)
- K860287PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-32Cleared 510(K)
- K854370MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K854201OMRON DIGITAL BP MONITOR HEM-700CP2Cleared 510(K)
- K853599LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI2Cleared 510(K)
- K852574WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C2Cleared 510(K)
- K852421SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR2Cleared 510(K)
- K852978COMFORT - CUF2Cleared 510(K)
- K852653HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81152Cleared 510(K)
- K852459HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81752Cleared 510(K)
- K852458HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81452Cleared 510(K)
- K852457HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81652Cleared 510(K)
- K853260OMRON DIGITAL BP MONITOR HEM-700C2Cleared 510(K)
- K852795SUNBEAM HEALTH MONITOR MODEL NO. 76002Cleared 510(K)
- K853158DIGITAL SPHYGMOMANOMETER MODEL 76202Cleared 510(K)
- K840574EBM-5002Cleared 510(K)
- K852128NORELCO ELECTRONIC DIGITAL BP METER HC35012Cleared 510(K)
- K851223COPAL DIGITAL SPHYGMOMANOMETER UA-5602Cleared 510(K)
- K852564COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K851707OMRON DIGITAL BP MONITOR HEM-400C2Cleared 510(K)
- K851664MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO2Cleared 510(K)
- K844252MODEL 9300 TREND ANALYZING BIO-MONITOR SYS2Cleared 510(K)
- K850830SHARP DIGITAL BP MONITOR MB-371H2Cleared 510(K)
- K852037NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER2Cleared 510(K)
- K843010BP-8002Cleared 510(K)
- K843055ACCU-TRAC2Cleared 510(K)
- K851049NORELCO BLOOD PRESSURE METER2Cleared 510(K)
- K850893BP/CLINIC SYS MEASUREMENT, BP NON-INVASIVE2Cleared 510(K)
- K850867ACCUTRACKER HEART-RATE MONITOR2Cleared 510(K)
- K843446DIGITAL SPHYGMOMANOMETER BP-25002Cleared 510(K)
- K843390COPAL DIGITAL SPHYGMOMANOMETER UA-5352Cleared 510(K)
- K850476NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-10502Cleared 510(K)
- K850477NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-20502Cleared 510(K)
- K850318UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-40502Cleared 510(K)
- K844310BLOOD-PRESSURE ECG TRANSMITTER2Cleared 510(K)
- K844285COPAL DIGITAL SPHYGMOMAMOMETER UA-5502Cleared 510(K)
- K850317UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-30502Cleared 510(K)
- K850315UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-10502Cleared 510(K)
- K850316UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-20502Cleared 510(K)
- K844839DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX2Cleared 510(K)
- K844353PHYSIOLOGICAL MONITOR 21002Cleared 510(K)
- K842538ACCUTORR CSM SYSTEM2Cleared 510(K)
- K842067CALCULATING CUFF INFLATOR TD3122Cleared 510(K)
- K842318YKI-770 ELECTRONIC SPHYGMOMAMETER2Cleared 510(K)
- K842388COPAL DIGITAL SPHYGMOMANOMETER UA-5102Cleared 510(K)
- K844284COPAL DIGITAL SPHYGMOMANOMETER UA-5402Cleared 510(K)
- K850070HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-22Cleared 510(K)
- K843137BP 50002Cleared 510(K)
- K841246PORTABLE NURSING UNIT TERMINAL2Cleared 510(K)
- K840932MUSE-DP2Cleared 510(K)
- K841336NON-INVASIVE BP MODULE 70002Cleared 510(K)
- K841103NONINVASIVE BLOOD PRESSURE MEASURE SYS2Cleared 510(K)
- K832076ELECTRONIC BLOOD PRESS. METER EN-2122Cleared 510(K)
- K842200MD308H DIGITAL/MB351H AUTO-BP MONITOR2Cleared 510(K)
- K843009BP-10002Cleared 510(K)
- K842486ELECTRONIC DIGITAL BP METER HC 30012Cleared 510(K)
- K841095BP800, 850 10002Cleared 510(K)
- K840909AUTOMATED NON-INVASIVE PRESSURE MODULE2Cleared 510(K)
- K841381DIGITAL SPHYGMOMANOMETER UA-2732Cleared 510(K)
- K841380DIGITAL SPHYGMOMANOMETER UA-2542Cleared 510(K)
- K841616TIMEX HEALTHCHECK DIGITAL BP MONITOR2Cleared 510(K)
- K840162DRAGER SPHYGMOMED2Cleared 510(K)
- K840469TYCOS SELF CHECK BPM3 BLOOD PRESS MONI2Cleared 510(K)
- K834441BLOOD PRESSURE MONITOR BP600X2Cleared 510(K)
- K833799SPHYGOMANO METER2Cleared 510(K)
- K840228HEALTHCHECK AUTO INFLATE DIGITAL BP2Cleared 510(K)
- K832721DIGITAL SPHYGMOMANOMETER UA-2312Cleared 510(K)
- K832722DIGITAL SPHYGMOMANOMETER UA-2512Cleared 510(K)
- K832723DIGITAL SPHGMOMANOMETER UA-2712Cleared 510(K)
- K833978OMEGA 50002Cleared 510(K)
- K833753AC ADAPTERS FOR BLOOD PRESSURE METERS2Cleared 510(K)
- K833583VERIFORM II2Cleared 510(K)
- K832764ALPHA NON-INVASIVE BP CARDULE2Cleared 510(K)
- K830338NARCOTRACE 802Cleared 510(K)
- K832656DINAMAP VITAL SIGNS MONITOR #1846P2Cleared 510(K)
- K832060ACCU-SPHYG2Cleared 510(K)
- K831245TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO2Cleared 510(K)
- K832171SELF CHECK DIGITAL BLOOD PRESS. MONITOR2Cleared 510(K)
- K832075ELECTRONIC BLOOD PRESS. METER-ZH-820P2Cleared 510(K)
- K831151PANASONIC MODEL EW-2132Cleared 510(K)
- K830682CARDIVAN BLOOD PRESSURE MONITOR2Cleared 510(K)
- K831232LIFESTAT 2002Cleared 510(K)
- K831583GP-3032Cleared 510(K)
- K831515DINAMAP VITAL SIGNS MONITOR #18462Cleared 510(K)
- K830713LS-1 PORTABLE BLOOD PRESSURE COMPUTER2Cleared 510(K)
- K830687NORELCO ELECTRONIC ANALOG BLOOD PRESS2Cleared 510(K)
- K830684NORELCO ELECTRONIC DIGITAL BLOOD PRESS2Cleared 510(K)
- K830685NORELCO DELUXE DIGITAL BLOOD PRESSURE2Cleared 510(K)
- K830686ANEROID BLOOD PRESSURE CUFF #HC14002Cleared 510(K)
- K830184SPHYGMOLOG II MODEL D2Cleared 510(K)
- K830368AMBULATORY BLOOD PRESSURE MONITOR2Cleared 510(K)
- K823501ZEE SPHYGMOMANOMETER2Cleared 510(K)
- K823052THE 500 MONITOR SERIES2Cleared 510(K)
- K822102PRESS-O-TEST2Cleared 510(K)
- K822055CNIBP BLOOD PRESSURE MEASUREMENT SYS2Cleared 510(K)
- K821989NON-STETHO 7, UM-15TP2Cleared 510(K)
- K822614BLOOD PRESSURE MONITORING DEVICES2Cleared 510(K)
- K822438BIOMEGA MODEL 59W2Cleared 510(K)
- K821614AS20 MONITORING SYSTEM2Cleared 510(K)
- K821378NON-INVASIVE AUTOMATIC BLOOD PRESSURE2Cleared 510(K)
- K820854KENZ-45M2Cleared 510(K)
- K821437DIGITAL BLOOD PRESSURE METER2Cleared 510(K)
- K820667PRESSURE-STAT2Cleared 510(K)
- K813522AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR2Cleared 510(K)
- K820300ELECTRONIC DIGITAL SPHYGMOMANOMETER2Cleared 510(K)
- K820569IVAC #1160 MULTIPLE VITAL SIGNS UNIT2Cleared 510(K)
- K820402PATIENT FOLLOW-UP COMPUTER (PFC2Cleared 510(K)
- K820242DIGICUFF2Cleared 510(K)
- K820135TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER2Cleared 510(K)
- K813385DIGITAL BLOOD PRESSURE UNIT2Cleared 510(K)
- K813556MOD. 587 BLOOD PRESSURE & PULSE MONITOR2Cleared 510(K)
- K813527DINAMAP ADULT/PED./NEONATAL VITAL SIGNS2Cleared 510(K)
- K812936BLOOD PRESSURE MONITOR2Cleared 510(K)
- K812409SPHYGMOMANOMETER2Cleared 510(K)
- K812259NIVP MONITOR2Cleared 510(K)
- K812059SPHGOMOMANOMETER2Cleared 510(K)
- K811781TENSIOMETER2Cleared 510(K)
- K811635NORELCO DIGITAL BLOOD PRESSURE METER2Cleared 510(K)
- K811636NORELCO ELECTRONIC BLOOD PRESSURE METER2Cleared 510(K)
- K811188NORELCO BLOOD PRESSURE METER2Cleared 510(K)
- K802412BLOOD PRESSURE UNIT MODEL 4102Cleared 510(K)
- K802411BLOOD PRESSURE UNIT MODEL 3102Cleared 510(K)
- K802191ATGM MODEL AT-802Cleared 510(K)
- K802218SD-900 OSCILLOMETRIC BP MONITOR2Cleared 510(K)
- K802202SD-800 BLOOD PRESSURE MONITOR2Cleared 510(K)
- K802201SD-700 BLOOD PRESSURE MONITOR2Cleared 510(K)
- K802203CM-700A AUTO-INFLATE CONTROL MODULE2Cleared 510(K)
- K801923BIOMEGA #423-B BLOOD PRESSURE & PULSE CK2Cleared 510(K)
- K801657NON-INVASIVE, BLOOD PRESSURE MONITOR2Cleared 510(K)
- K801389BARO/TRAC II & VITA/TRAC, VITAL SIGN MON2Cleared 510(K)
- K800596VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR2Cleared 510(K)
- K801187CONPHAR CHECKMATE SPHYGMOMANOMETER2Cleared 510(K)
- K800904TONOTEST BLOOD PRESSURE MONITOR2Cleared 510(K)
- K800778DIGITAL ELECTRONIC B.P. MONITOR 21552Cleared 510(K)
- K800661MODEL S/D-600 AUTO INFLATE CONTROL MODUL2Cleared 510(K)
- K800663MARK III2Cleared 510(K)
- K800662MARK II2Cleared 510(K)
- K800614MEDTEK #411 PORTABLE B-P INSTR.2Cleared 510(K)
- K800401INFRASONDE D4000 ELECTRONIC B-P MONITOR2Cleared 510(K)
- K800225MICRONTA BP-1 ELECTRONIC B/P TESTER2Cleared 510(K)
- K800066NIASTAT2Cleared 510(K)
- K800025DINAMAP RESEARCH MONITOR 12452Cleared 510(K)
- K792653SENTRY2Cleared 510(K)
- K792075MODEL 1978 PRESSUROMETER III AMBULATORY2Cleared 510(K)
- K792194VITA-STAT MODEL 900-S2Cleared 510(K)
- K792193VITA-STAT MODEL 900-D2Cleared 510(K)
- K792192VITA-STAT MODEL 900A2Cleared 510(K)
- K791637TENS-O-TEST2Cleared 510(K)
- K791159DINAMAP MODEL 8552Cleared 510(K)
- K791054HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC2Cleared 510(K)
- K790537AUTOMATIC ELECTRONIC SPHYMOMONOMETER2Cleared 510(K)
- K790470THE GUARDIAN SPHYGMOMANOMETER2Cleared 510(K)
- K790277QUICK-CHECK2Cleared 510(K)
- K790328MODEL 1051, MONITOR2Cleared 510(K)
- K781517AUTOMATIC BLOOD PRESSURE DEVICE2Cleared 510(K)
- K782000MONITOR, NON-INVASIVE BLOOD PRESSURE2Cleared 510(K)
- K781932BLOOD PRESSURE RECORDER2Cleared 510(K)
- K781906BLOOD PRESSURE DEVICE, 400 SERIES2Cleared 510(K)
- K781556PRESSURE INFUSION CUFF2Cleared 510(K)
- K780986DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K780754NEONATAL MONITOR2Cleared 510(K)
- K780805S/D 600 SPHYGMOMANOMETER AND PULSEMETER2Cleared 510(K)
- K780598TREND II ANEROID2Cleared 510(K)
- K780358ACCES. ANALOG OUTPUT ADAPTOR MODEL 9102Cleared 510(K)
- K780566HEALTH SEAT SYSTEM2Cleared 510(K)
- K780046ULTRASPHYG BLOOD PRESSURE OPTION2Cleared 510(K)
- K771393ELHCTRONIC SPHYGMOMANOMETER2Cleared 510(K)
- K771394ELECTRONIC STETHESCOPE2Cleared 510(K)
- K771931MONITOR, DINMAP, MODEL 8502Cleared 510(K)
- K771895DINAMAP MADEL 8452Cleared 510(K)
- K771897DINAMAP MODEL 8372Cleared 510(K)
- K771896DINAMAP MODEL 8352Cleared 510(K)
- K771782DINIMAP MODEL 827A2Cleared 510(K)
- K771449ARTEOIAL TONOMETER ML-1052Cleared 510(K)
- K771500PRESSUROMETER II2Cleared 510(K)
- K770921SPHYGMOMANOMETER, ELECTRONIC2Cleared 510(K)
- K770357SPHYGMOMANOMETER, ELECTRONIC2Cleared 510(K)
- K760738AUTOMATIC ELECTRONIC SPHYGMOMANOMETER2Cleared 510(K)
- K761274BLOOD PRESSURE KIT, WELL-BE 6692Cleared 510(K)
- K761302ELECTRONIC BLOOD PRESSURE UNIT2Cleared 510(K)
- K761057ARTERIOSONDE BLOOD PRESS. MNTR. (#1020)2Cleared 510(K)
- K760930BLOOD PRESSURE & PULSE CHECKER2Cleared 510(K)
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221833
- 510(k) Type
- Traditional
- Applicant
- Edwards Life Sciences LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/7/2022
- Days to Decision
- 137 days
- Submission Type
- Summary