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
- 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
- K240312Infinity CentralStation Wide2Cleared 510(K)
- K240320Patient Monitor (RespArray)2Cleared 510(K)
- K231010Corvair2Cleared 510(K)
- K232962Patient Monitor (iX10, iX12, iX15)2Cleared 510(K)
- K232694Central Monitoring System (MFM-CMS)2Cleared 510(K)
- K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)2Cleared 510(K)
- K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)2Cleared 510(K)
- K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+2Cleared 510(K)
- K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)2Cleared 510(K)
- K221056ARGUS PB-30002Cleared 510(K)
- K223498Radius VSM and Accessories2Cleared 510(K)
- K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)2Cleared 510(K)
- K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)2Cleared 510(K)
- K211619Multi-Parameter Patient Monitor2Cleared 510(K)
- K222586Mural Clinical Viewer2Cleared 510(K)
- K221904EK12 V2 Algorithm2Cleared 510(K)
- K220308Patient Monitor: RespArray2Cleared 510(K)
- K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-152Cleared 510(K)
- K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-172Cleared 510(K)
- K220989Next Generation NetKonnect2Cleared 510(K)
- K213799N Series Patient Monitors2Cleared 510(K)
- K213363CARESCAPE B450, E-musb2Cleared 510(K)
- K213336Carescape B850, E-musb2Cleared 510(K)
- K213181CARESCAPE B650, E-musb2Cleared 510(K)
- K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS2012Cleared 510(K)
- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P2Cleared 510(K)
- K211900Patient Information Center iX2Cleared 510(K)
- K203088Infinity Acute Care System (IACS) Monitoring System2Cleared 510(K)
- K201764Infinity Acute Care System (IACS) Monitoring Solution2Cleared 510(K)
- K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-42Cleared 510(K)
- K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System2Cleared 510(K)
- K202336Patient Monitor2Cleared 510(K)
- K202405BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N12Cleared 510(K)
- K201941Monitor B125, Monitor B1052Cleared 510(K)
- K201746Tempus Pro Patient Monitor2Cleared 510(K)
- K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX5502Cleared 510(K)
- K200859Infinity M3002Cleared 510(K)
- K200015ePM Series Patient monitors2Cleared 510(K)
- K192972Patient Monitor2Cleared 510(K)
- K192514Patient Monitor2Cleared 510(K)
- K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES2Cleared 510(K)
- K191323Carescape B8502Cleared 510(K)
- K191249CARESCAPE B4502Cleared 510(K)
- K191149CARESCAPE B6502Cleared 510(K)
- K190008Carescape One2Cleared 510(K)
- K190939ZOLL Arrhythmia Management Sysyem2Cleared 510(K)
- K191106C50 and C80 Multi-parameter Patient Monitor2Cleared 510(K)
- K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X32Cleared 510(K)
- K191769ePM Series Patient monitors2Cleared 510(K)
- K183387M3290B Patient Information Center iX2Cleared 510(K)
- K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)2Cleared 510(K)
- K173036North-vision Multi-parameter Patient Monitor2Cleared 510(K)
- K182075BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)2Cleared 510(K)
- K180482ZOLL Propaq M2Cleared 510(K)
- K181831IntelliVue Multi-Measurement Module MMX2Cleared 510(K)
- K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension2Cleared 510(K)
- K173765Surveyor Patient Monitor2Cleared 510(K)
- K173454Multi-parameter Patient Monitor, models C302Cleared 510(K)
- K180017MX40 Release C.012Cleared 510(K)
- K180472ViSi Mobile Monitoring System2Cleared 510(K)
- K172510µCor Heart Failure and Arrhythmia Management System2Cleared 510(K)
- K173768Tempus Pro Patient Monitor2Cleared 510(K)
- K172966CMS-2000 Central Monitoring System2Cleared 510(K)
- K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)2Cleared 510(K)
- K172226MX40 Release B.072Cleared 510(K)
- K171580Monitor B125, Monitor B1052Cleared 510(K)
- K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable2Cleared 510(K)
- K170876Passport Series Patient Monitors(Passport 12m, Passport 17m)2Cleared 510(K)
- K163584M3290B Philips IntelliVue Information Center iX2Cleared 510(K)
- K170567Tempus Pro Patient Monitor2Cleared 510(K)
- K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor2Cleared 510(K)
- K170155EK12 Algorithm2Cleared 510(K)
- K170514Central Monitoring System2Cleared 510(K)
- K163459Nihon Kohden Vital Sign Telemeter2Cleared 510(K)
- K161056Telemetry Transmitter2Cleared 510(K)
- K161517Mortara Surveyor Patient Monitor2Cleared 510(K)
- K160981Patient Monitor2Cleared 510(K)
- K153707Nihon Kohden Vital Sign Telemeter2Cleared 510(K)
- K160685Surveyor S4 Mobile Monitor2Cleared 510(K)
- K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX8002Cleared 510(K)
- K153702M3290B Philips IntelliVue Information Center iX2Cleared 510(K)
- K160951Philips Efficia CMS200 Central Monitoring System2Cleared 510(K)
- K152973Dyna-Vision Telemonitoring System2Cleared 510(K)
- K152552Patient Monitor2Cleared 510(K)
- K153160AVIVO Mobile Patient Management (MPM) System2Cleared 510(K)
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)2Cleared 510(K)
- K153275Aingeal Activity System2Cleared 510(K)
- K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)2Cleared 510(K)
- K151812PATIENT MONITORS VARIOUS MODELS2Cleared 510(K)
- K151063Monitor B402Cleared 510(K)
- K151080Nihon Kohden CSM 1901 Bedside Monitor2Cleared 510(K)
- K150329elance Vital Signs Monitor, Central Monitor Software2Cleared 510(K)
- K151027zensor system2Cleared 510(K)
- K152407Infinity Delta, Infinity Delta XL, Infinity Kappa2Cleared 510(K)
- K151860Infinity CentralStation Wide2Cleared 510(K)
- K150352V Series Monitoring System (including V12 and V21 Monitors)2Cleared 510(K)
- K150082Panorama Patient Monitoring Network2Cleared 510(K)
- K143676B40i Patient Monitor2Cleared 510(K)
- K142827Visi Mobile Monitoring System, Visi Mobile Chest Sensor2Cleared 510(K)
- K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors2Cleared 510(K)
- K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor2Cleared 510(K)
- K134046FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR2Cleared 510(K)
- K14196312SL ECG ANALYSIS PROGRAM2Cleared 510(K)
- K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)2Cleared 510(K)
- K141811MORTARA MONITORING WAVEFORM VIEWER2Cleared 510(K)
- K142601Panorama Patient Monitoring Network2Cleared 510(K)
- K141156SPACELABS HEALTHCARE TELEMETRY RECEIVER2Cleared 510(K)
- K133222SAAD PATIENT MONITOR (SPM)2Cleared 510(K)
- K132662PASSPORT SERIES PATIENT MONITORS2Cleared 510(K)
- K141015INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT2Cleared 510(K)
- K132077PATIENT MONITOR2Cleared 510(K)
- K132075PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)2Cleared 510(K)
- K131971IM60/IM70 PATIENT MONITOR2Cleared 510(K)
- K131876M SERIES PATIENT MONITOR2Cleared 510(K)
- K133576MONITOR B402Cleared 510(K)
- K130401ALERTWATCH: OR2Cleared 510(K)
- K132026V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V212Cleared 510(K)
- K130208BERNOULLI ENTERPRISE SOFTWARE2Cleared 510(K)
- K132533CARESCAPE MONITOR B4502Cleared 510(K)
- K131929SURVEYOR CENTRAL STATION2Cleared 510(K)
- K131872INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX5502Cleared 510(K)
- K131414CARESCAPE MONITOR B8502Cleared 510(K)
- K131223CARESCAPE MONITOR B6502Cleared 510(K)
- K131829INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K131032PHILIPS SURESIGNS CENTRAL2Cleared 510(K)
- K131763TRUSCOPE SERIES PATIENT MONITOR2Cleared 510(K)
- K123074IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS2Cleared 510(K)
- K130584MONITOR B402Cleared 510(K)
- K120727MFM-CMS CENTRAL MONITORING SYSTEM2Cleared 510(K)
- K130849INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX4502Cleared 510(K)
- K122146XHIBIT CENTRAL STATION, MODEL 961022Cleared 510(K)
- K123900SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM82Cleared 510(K)
- K130711INFINITY CENTRALSTATION WITH INFINITY M3002Cleared 510(K)
- K123556MORTARA SURVEYOR PATIENT MONITOR2Cleared 510(K)
- K122253PROCARE MONITOR B202Cleared 510(K)
- K123472CIMVA UNIVERSAL2Cleared 510(K)
- K123048PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO2Cleared 510(K)
- K122439INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K113045BIOHARNESS2Cleared 510(K)
- K120598PROCARE MONITOR B402Cleared 510(K)
- K120366INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K121367ZOLL PROPAQ XM2Cleared 510(K)
- K121480ARIATELE TELEMETRY TRANSMITTER (96281)2Cleared 510(K)
- K120631PATIENT MONITOR2Cleared 510(K)
- K120173PATIENT MONITOR2Cleared 510(K)
- K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (913902Cleared 510(K)
- K113798INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET2Cleared 510(K)
- K113657INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K113441PHYSIOLOGICAL MONITOR, PATIENT MONITOR2Cleared 510(K)
- K113054EQUIVITAL2Cleared 510(K)
- K113653PATIENT MONITOR2Cleared 510(K)
- K113623PATIENT MONITOR2Cleared 510(K)
- K113187AVIVO MOBILE PATIENT MANAGEMENT2Cleared 510(K)
- K112637NETKONNECT REMOTE NETWORK EXTENSION2Cleared 510(K)
- K112190PATIENT MONITOR2Cleared 510(K)
- K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)2Cleared 510(K)
- K112803PATIENT MONITOR2Cleared 510(K)
- K110922PATIENT MONITOR2Cleared 510(K)
- K101692PATIENT MONITOR2Cleared 510(K)
- K110953VISENSIA, VISENSIA WITH ALERT2Cleared 510(K)
- K110015VITALSENS, AINGEAL, V-POD2Cleared 510(K)
- K110622INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K103134FUKUDA DENSHI2Cleared 510(K)
- K103652SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM82Cleared 510(K)
- K103646INTELLIVUE MX40 PATIENT MONITOR2Cleared 510(K)
- K102422SPACELABS MEDICAL PATIENT MONITORS2Cleared 510(K)
- K102376NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-62012Cleared 510(K)
- K100040BIOHARNESS2Cleared 510(K)
- K101619WELCH ALLYN 1500 PATIENT MONITOR2Cleared 510(K)
- K102562INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX8002Cleared 510(K)
- K102239CARESCAPE MONITOR B6502Cleared 510(K)
- K102495M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.02Cleared 510(K)
- K102040PATIENT MONITOR2Cleared 510(K)
- K102004ENDEAVOUR MONITORING SYSTEM2Cleared 510(K)
- K092449BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T52Cleared 510(K)
- K101521ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O2Cleared 510(K)
- K101449INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K100217LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M302Cleared 510(K)
- K093268INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K101067SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 8630682Cleared 510(K)
- K100939INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP902Cleared 510(K)
- K100046M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M70002Cleared 510(K)
- K093788INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION2Cleared 510(K)
- K09236912SL ECG ANALYSIS PROGRAM2Cleared 510(K)
- K092970GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H2Cleared 510(K)
- K093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION2Cleared 510(K)
- K092680DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN2Cleared 510(K)
- K092027CARESCAPE MONITOR B8502Cleared 510(K)
- K091594HEART-EXERCISE2Cleared 510(K)
- K091834PASSPORT V MONITOR, MODEL 0998-00-61002Cleared 510(K)
- K091395MP5 INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K090443PLANET 55, MODEL 1002Cleared 510(K)
- K090172STAR 55 MODEL 1002Cleared 510(K)
- K090556SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE2Cleared 510(K)
- K090702MODIFICATION TO DASH 2500 PATIENT MONITOR2Cleared 510(K)
- K083750CAPNOSTAT / CAPNOFLEX CO2 SYSTEM2Cleared 510(K)
- K083697FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M2Cleared 510(K)
- K082583INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC52Cleared 510(K)
- K083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY2Cleared 510(K)
- K082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES2Cleared 510(K)
- K083228PHILIPS INTELLIVUE MP5 PATIENT MONITOR2Cleared 510(K)
- K081793PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER2Cleared 510(K)
- K082280SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR2Cleared 510(K)
- K081891FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR2Cleared 510(K)
- K081983M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.002Cleared 510(K)
- K082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 912202Cleared 510(K)
- K081140VISENSIA2Cleared 510(K)
- K073280BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T52Cleared 510(K)
- K080251APEXPRO TELEMETRY SYSTEMS2Cleared 510(K)
- K073550PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION2Cleared 510(K)
- K080495SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS32Cleared 510(K)
- K080157DASH 2500 PATIENT MONITOR2Cleared 510(K)
- K080342NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES2Cleared 510(K)
- K073462MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES2Cleared 510(K)
- K071164LIFE+CEL BATTERY2Cleared 510(K)
- K073203CARESCAPE V1002Cleared 510(K)
- K072346PM-7000 PATIENT MONITOR2Cleared 510(K)
- K072070PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS2Cleared 510(K)
- K070791PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS2Cleared 510(K)
- K071020DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE2Cleared 510(K)
- K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS2Cleared 510(K)
- K070566INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL2Cleared 510(K)
- K071073SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE2Cleared 510(K)
- K063690COLIN PRESS MATE, MODEL BP S5102Cleared 510(K)
- K062194HYPERVISOR VI CENTRAL MONITORING SYSTEM2Cleared 510(K)
- K070588PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)2Cleared 510(K)
- K061379INFINITY TELESMART TELEMETRY SYSTEM2Cleared 510(K)
- K063725MP5 INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K062098SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX2Cleared 510(K)
- K062324MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN2Cleared 510(K)
- K062271M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)2Cleared 510(K)
- K063315INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP902Cleared 510(K)
- K061993EQUIVITAL, MODEL EQ-012Cleared 510(K)
- K062144ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 38102Cleared 510(K)
- K062576DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES2Cleared 510(K)
- K062095MCARE 300 VITAL SIGNS MONITOR, MODEL 912202Cleared 510(K)
- K062283THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS2Cleared 510(K)
- K062392PHILIPS MP5 INTELLIVUE PATIENT MONITOR2Cleared 510(K)
- K061610PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS2Cleared 510(K)
- K061675VISION VXC CENTRAL STATION, MODEL 43002Cleared 510(K)
- K06083312SL ECG ANALYSIS PROGRAM2Cleared 510(K)
- K060281VS-800 VITAL SIGNS MONITOR2Cleared 510(K)
- K061052THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP902Cleared 510(K)
- K053207ARGUS, MODEL LCM2Cleared 510(K)
- K061185DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE2Cleared 510(K)
- K060135MORTARA SURVEYOR TELEMETRY CENTRAL STATION2Cleared 510(K)
- K060223INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM2Cleared 510(K)
- K060039INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS2Cleared 510(K)
- K053121TRAM MODULE2Cleared 510(K)
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- K060221THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS2Cleared 510(K)
- K051217DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)2Cleared 510(K)
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- K053522PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.002Cleared 510(K)
- K051658INFINITY ALPHA2Cleared 510(K)
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- K051367PATIENT MONITOR, MODELS DASH 3000, 4000 AND 50002Cleared 510(K)
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- K043551DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES2Cleared 510(K)
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- K042904INFINITY KAPPA XLT2Cleared 510(K)
- K050141THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS2Cleared 510(K)
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- K041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN2Cleared 510(K)
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- K040395CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES2Cleared 510(K)
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- K041087INFINITY GAMMA2Cleared 510(K)
- K040955M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN2Cleared 510(K)
- K033694INFINITY MODULAR MONITORS VF4 MODIFICATIONS2Cleared 510(K)
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- K030931C3 PATIENT MONITOR2Cleared 510(K)
- K031320EK-PRO ARRHYTHMIA DETECTION ALGORITHM2Cleared 510(K)
- K030613VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 81002Cleared 510(K)
- K030657SIEMENS INFINITY GATEWAY SUITE, MODEL VF22Cleared 510(K)
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- K030431MODIFICATION TO DASH 3000/4000 PATIENT MONITOR2Cleared 510(K)
- K030313SIEMENS INFINITY SC 6002XL MODIFICATIONS2Cleared 510(K)
- K024108SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM2Cleared 510(K)
- K023871M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY2Cleared 510(K)
- K023674PHILIPS DRUG CALCULATOR SOFTWARE2Cleared 510(K)
- K023698M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O2Cleared 510(K)
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- K023475CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES2Cleared 510(K)
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- K022889SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER2Cleared 510(K)
- K020290DASH 3000/4000 PATIENT MONITOR2Cleared 510(K)
- K021279DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE2Cleared 510(K)
- K021422PHILIPS INFORMATION CENTER SOFTWARE REVISION D.022Cleared 510(K)
- K021325MODIFICATION OF APEXPRO TELEMETRY SYSTEM2Cleared 510(K)
- K012226MONITORING SYSTEM,MODEL ARGUS PB-10002Cleared 510(K)
- K012915DINAMAP PRO 1000 MONITOR, MODEL 10002Cleared 510(K)
- K020531PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B2Cleared 510(K)
- K014261ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.02Cleared 510(K)
- K011540VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-072Cleared 510(K)
- K010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E2Cleared 510(K)
- K014213SIEMENS INFINITY GATEWAY SUITE2Cleared 510(K)
- K013311MODIFICATION TO: POCKETVIEW ECG SOFTWARE2Cleared 510(K)
- K013624MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I2Cleared 510(K)
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- K013199PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B2Cleared 510(K)
- K011918NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES2Cleared 510(K)
- K012016INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II2Cleared 510(K)
- K011000TRAM 2001 MODULE2Cleared 510(K)
- K011093AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M31542Cleared 510(K)
- K003248SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER2Cleared 510(K)
- K003243SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL2Cleared 510(K)
- K003621ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.02Cleared 510(K)
- K001433CNS-9300 SERIES CENTRAL STATION2Cleared 510(K)
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- K002478S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A082Cleared 510(K)
- K002158S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE2Cleared 510(K)
- K000517LIFE SCOPE EC, MODEL BSM-11022Cleared 510(K)
- K002209GE MARQUETTE ECG ANALYSIS PROGRAM2Cleared 510(K)
- K001268GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS2Cleared 510(K)
- K001722AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE2Cleared 510(K)
- K001664COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J1202Cleared 510(K)
- K000815AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)2Cleared 510(K)
- K000882DATEX-OHMEDA CS/3 TELEMETRY SYSTEM2Cleared 510(K)
- K001348ST/AR ST AND ARRHYTHMIA SOFTWARE2Cleared 510(K)
- K000563MODIFICATION TO ENVOY PATIENT MONITOR2Cleared 510(K)
- K000168CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)2Cleared 510(K)
- K993608DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)2Cleared 510(K)
- K000854VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER2Cleared 510(K)
- K993974SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR2Cleared 510(K)
- K992273HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B2Cleared 510(K)
- K992595HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH2Cleared 510(K)
- K992929DASH 3000 PATIENT MONITOR2Cleared 510(K)
- K992674HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A2Cleared 510(K)
- K990476HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION2Cleared 510(K)
- K990068SOLAR 9500 INFORMATION MONITOR2Cleared 510(K)
- K983996SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM2Cleared 510(K)
- K990563SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION2Cleared 510(K)
- K982091CS/3 COMPACT AIRWAY MODULE, M-COVX2Cleared 510(K)
- K982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 92002Cleared 510(K)
- K980619SABRATEK PATIENT HOME MANAGEMENT SYSTEM2Cleared 510(K)
- K980411NPB3900 SERIES PATIENT MONITORS2Cleared 510(K)
- K981576MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A2Cleared 510(K)
- K973474WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS2Cleared 510(K)
- K971840OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM2Cleared 510(K)
- K970445VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 3002Cleared 510(K)
- K972535MAGLIFE C2Cleared 510(K)
- K970182DINAMAP COMPACT MONITOR2Cleared 510(K)
- K922668PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM2Cleared 510(K)
- K962424NPB-40002Cleared 510(K)
- K950264MAGLIFE2Cleared 510(K)
- K950436WITT BIOMEDICAL SERIES IV2Cleared 510(K)
- K945099PARAMETERS MONITORES2Cleared 510(K)
- K944860SCHOLAR PATIENT MONITOR2Cleared 510(K)
- K944495MODEL 3200 VASCULAR MINI-LAB2Cleared 510(K)
- K950536PICIS CHART+2Cleared 510(K)
- K942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/93402Cleared 510(K)
- K945385VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 3002Cleared 510(K)
- K945134PORTABLE PATIENT MONITOR2Cleared 510(K)
- K933624VITALMAX 40002Cleared 510(K)
- K922210HEWLETT-PACKARD MODEL 78730 CAREVUE 50002Cleared 510(K)
- K924575ATLANTIS GUI2Cleared 510(K)
- K920445SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES2Cleared 510(K)
- K923054WITT BIOMEDICAL SERIES II-EP2Cleared 510(K)
- K922974PORTABLE PATIENT MONITOR2Cleared 510(K)
- K922058MODELS M1175A AND M1176A COMPONENT MONITORING SYST2Cleared 510(K)
- K921014MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR2Cleared 510(K)
- K911646NGM ESTP MODULE2Cleared 510(K)
- K912835MINI-PACK 911 SERIES2Cleared 510(K)
- K914838PROPAQ 102,104,106,102EL,104EL,&106EL2Cleared 510(K)
- K912188DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 87002Cleared 510(K)
- K913263VITALMAX 830 SERIES2Cleared 510(K)
- K912627MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM2Cleared 510(K)
- K911051MONARCH SYSTEM2Cleared 510(K)
- K881643BATTERY PACKS FOR CARDIOVASCULAR UNITS2Cleared 510(K)
- K872476REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION2Cleared 510(K)
- 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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EK12 V2 Algorithm
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221904
- 510(k) Type
- Traditional
- Applicant
- GE Medical Systems Information Technologies, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/20/2022
- Days to Decision
- 173 days
- Submission Type
- Summary