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)
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- 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)
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- K001848OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-9072Cleared 510(K)
- K001670AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-7572Cleared 510(K)
- K001671ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-6302Cleared 510(K)
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- K993316UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE2Cleared 510(K)
- K000500DINAMAP ADVANCED NIBP MODULE2Cleared 510(K)
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- K994423AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-1002Cleared 510(K)
- K993938THE HOMMED SENTRY, MODEL 1 SENTRY2Cleared 510(K)
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- K984083MULTIFUNCTION KEITO K52Cleared 510(K)
- K993460ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z432Cleared 510(K)
- K993426ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z442Cleared 510(K)
- K993429ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z402Cleared 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)
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- 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)
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- K982641ADVANCED NIBP MODULE2Cleared 510(K)
- K984618BCI MINI-TORR PLUS, MODEL 60042Cleared 510(K)
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- 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)
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- K980824A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
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- K972795CARDIO-CARD MANAGEMENT SYSTEM II2Cleared 510(K)
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- K954547CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER2Cleared 510(K)
- K961144MS-20002Cleared 510(K)
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- 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)
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- 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)
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- 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)
- K895429A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 26502Cleared 510(K)
- K895428A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/202Cleared 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)
- K881601OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C2Cleared 510(K)
- K881602OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C2Cleared 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)
- K852457HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81652Cleared 510(K)
- K852458HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81452Cleared 510(K)
- K852459HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81752Cleared 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)
- K850477NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-20502Cleared 510(K)
- K850476NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-10502Cleared 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)
- K850316UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-20502Cleared 510(K)
- K850315UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-10502Cleared 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)
- K832723DIGITAL SPHGMOMANOMETER UA-2712Cleared 510(K)
- K832722DIGITAL SPHYGMOMANOMETER UA-2512Cleared 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)
- K830685NORELCO DELUXE DIGITAL BLOOD PRESSURE2Cleared 510(K)
- K830686ANEROID BLOOD PRESSURE CUFF #HC14002Cleared 510(K)
- K830687NORELCO ELECTRONIC ANALOG BLOOD PRESS2Cleared 510(K)
- K830684NORELCO ELECTRONIC DIGITAL BLOOD PRESS2Cleared 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)
- K811636NORELCO ELECTRONIC BLOOD PRESSURE METER2Cleared 510(K)
- K811635NORELCO DIGITAL 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)
- K800663MARK III2Cleared 510(K)
- K800662MARK II2Cleared 510(K)
- K800661MODEL S/D-600 AUTO INFLATE CONTROL MODUL2Cleared 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)
- K771896DINAMAP MODEL 8352Cleared 510(K)
- K771895DINAMAP MADEL 8452Cleared 510(K)
- K771897DINAMAP MODEL 8372Cleared 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
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BCI MODEL 6004 NIBP MONITOR (6004)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K970801
- 510(k) Type
- Traditional
- Applicant
- BCI INTL., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/12/1997
- Days to Decision
- 253 days
- Submission Type
- Summary