Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- DSMAlarm, Leakage Current, Portable1Product Code
- DPSElectrocardiograph2Product Code
- DPTProbe, Blood-Flow, Extravascular2Product Code
- DPWFlowmeter, Blood, Cardiovascular2Product Code
- DQBPhlebograph, Impedance2Product Code
- DQCPhonocardiograph1Product Code
- DQHCardiograph, Apex (Vibrocardiograph)2Product Code
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2Product Code
- DRIMonitor, Line Isolation1Product Code
- DRJSystem, Signal Isolation1Product Code
- DRQAmplifier And Signal Conditioner, Transducer Signal2Product Code
- DRRAmplifier And Signal Conditioner, Biopotential2Product Code
- DRSTransducer, Blood-Pressure, Extravascular2Product Code
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)2Product Code
- DRWAdaptor, Lead Switching, Electrocardiograph2Product Code
- DRXElectrode, Electrocardiograph2Product Code
- DRZOscillometer2Product Code
- DSACable, Transducer And Electrode, Patient, (Including Connector)2Product Code
- DSBPlethysmograph, Impedance2Product Code
- DSFRecorder, Paper Chart1Product Code
- DSHRecorder, Magnetic Tape, Medical2Product Code
- DXHTransmitters And Receivers, Electrocardiograph, Telephone2Product Code
- DXJDisplay, Cathode-Ray Tube, Medical2Product Code
- DXKEchocardiograph2Product Code
- DXOTransducer, Pressure, Catheter Tip2Product Code
- DXPTransducer, Vessel Occlusion2Product Code
- DXRBallistocardiograph2Product Code
- DYCVectorcardiograph2Product Code
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic2Product Code
- JONTransducer, Apex Cardiographic2Product Code
- JOOTransducer, Heart Sound2Product Code
- JOPTransducer, Ultrasonic2Product Code
- KRCTester, Electrode, Surface, Electrocardiographic2Product Code
- MLCMonitor, St Segment2Product Code
- MLNElectrode, Electrocardiograph, Multi-Function2Product Code
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2Product Code
- MSXSystem, Network And Communication, Physiological Monitors2Product Code
- MUDOximeter, Tissue Saturation2Product Code
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2Product Code
- K241958WARD-CSS (v1.2.x)2Cleared 510(K)
- K243146iCare APP2Cleared 510(K)
- K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)2Cleared 510(K)
- K243216Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)2Cleared 510(K)
- K233446AMC Health CareConsole2Cleared 510(K)
- K240236Happy Ring Health Monitoring System2Cleared 510(K)
- K233354WVSM Pro (Series) (500-0030-XX)2Cleared 510(K)
- K232111NeoBeat, NeoBeat Mini2Cleared 510(K)
- K233810Portrait VSM2Cleared 510(K)
- K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)2Cleared 510(K)
- K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O2Cleared 510(K)
- K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s2Cleared 510(K)
- K231086CPM System2Cleared 510(K)
- K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal2Cleared 510(K)
- K230881Change Healthcare Cardiology Hemodynamics™2Cleared 510(K)
- K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™2Cleared 510(K)
- K220117ARC Intensive Care Information System (ARC System)2Cleared 510(K)
- K230214Huma RPM (RPM)2Cleared 510(K)
- K222330The Heart Seat2Cleared 510(K)
- K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories2Cleared 510(K)
- K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor2Cleared 510(K)
- K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor2Cleared 510(K)
- K212473Welch Allyn Connex Central Station2Cleared 510(K)
- K212975MedWand2Cleared 510(K)
- K213335Capsule Surveillance System2Cleared 510(K)
- K211754Vital Signs Monitor2Cleared 510(K)
- K210204Capsule Vitals Plus Patient Monitoring System2Cleared 510(K)
- K211475Vital Signs Monitors2Cleared 510(K)
- K212227Philips MR Patient Care Portal2Cleared 510(K)
- K210086Vitals360 Multi-Vitals Mobile Monitor2Cleared 510(K)
- K202375ZOLL Propaq M2Cleared 510(K)
- K200160740 SafeSAT2Cleared 510(K)
- K201635MouthLab Vital Signs Monitoring System2Cleared 510(K)
- K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s2Cleared 510(K)
- K202306T3 Platform software2Cleared 510(K)
- K193626Masimo Rad-97 Pulse CO-Oximeter and Accessories2Cleared 510(K)
- K200856SmartLinx Vitals Plus Patient Monitoring System2Cleared 510(K)
- K200141Oxi-W System2Cleared 510(K)
- K191882Masimo Centroid System2Cleared 510(K)
- K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories2Cleared 510(K)
- K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCap2Cleared 510(K)
- K192004Eko Analysis Software2Cleared 510(K)
- K191059Masimo Rad-97 and Accessories2Cleared 510(K)
- K190273T3 Platform software2Cleared 510(K)
- K183687LifeWindow LW8 Lite2Cleared 510(K)
- K183370PeraMobile and PeraWatch2Cleared 510(K)
- K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter2Cleared 510(K)
- K190090DynoSense Vital Sign Measuring System2Cleared 510(K)
- K190468Nihon Kohden SVM-7200 Series Vital Signs Monitor2Cleared 510(K)
- K183697Masimo Rad-97 and Accessories2Cleared 510(K)
- K183634Stasis Monitoring System2Cleared 510(K)
- K183638SmartLinx Vitals Plus Patient Monitoring System2Cleared 510(K)
- K181541Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK2Cleared 510(K)
- K181919Patient Monitor2Cleared 510(K)
- K1809033880 MRI Patient Monitoring System2Cleared 510(K)
- K182821Accutorr 7/VS-900/VS-900c Vital Signs Monitor2Cleared 510(K)
- K172965Handheld VitalSigns Monitoring System2Cleared 510(K)
- K1829003880 MRI Patient Monitoring System2Cleared 510(K)
- K183116Unity Network ID2Cleared 510(K)
- K182226AirStrip RPM InvisionHeart Adapter2Cleared 510(K)
- K181311Philips Hemodynamic Application R1.02Cleared 510(K)
- K180734SmartLinx Vitals Plus Patient Monitoring System2Cleared 510(K)
- K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM1002Cleared 510(K)
- K172147STAR 652Cleared 510(K)
- K172959PeraServer and PeraTrend2Cleared 510(K)
- K171361BETTERCARE PLATFORM - ADVANCED WEB CLIENT2Cleared 510(K)
- K171056WAVE Clinical Platform2Cleared 510(K)
- K171121Masimo Root Monitoring System and Accessories2Cleared 510(K)
- K1722003880 MRI Patient Monitoring System2Cleared 510(K)
- K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module2Cleared 510(K)
- K170538RVS-100 Vital Signs Monitor2Cleared 510(K)
- K170168Masimo Rad-97 and Accessories2Cleared 510(K)
- K170047All-in-One Health Monitor, PC-3032Cleared 510(K)
- K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP2Cleared 510(K)
- K170712Accutorr 7/VS-900 Vital Signs Monitor2Cleared 510(K)
- K170798Dictum Health2Cleared 510(K)
- K160899CoVa Monitoring System 22Cleared 510(K)
- K163065T3 Software2Cleared 510(K)
- K170199Unity Network ID2Cleared 510(K)
- K162234Truscope Ultra Patient Monitor2Cleared 510(K)
- K161909IQvitals Zone2Cleared 510(K)
- K160718Vital Sync Informatics Manager & Virtual Patient Monitoring Platform2Cleared 510(K)
- K151839AMC Health VitalCaregiving System2Cleared 510(K)
- K160956LD-Oxi system2Cleared 510(K)
- K153739MRI Patient Monitor TeslaDUO2Cleared 510(K)
- K153225Masimo Root Monitoring System and Accessories2Cleared 510(K)
- K153079Axeo 3 Patient Monitor2Cleared 510(K)
- K153335AlertWatch: OR2Cleared 510(K)
- K153135VITAL SIGNS MONITOR2Cleared 510(K)
- K151512Star 602Cleared 510(K)
- K151644Masimo Root Vital Signs Monitoring System and Accessories2Cleared 510(K)
- K152645Dictum Health2Cleared 510(K)
- K152330Expression MR400 MRI Patient Monitoring System2Cleared 510(K)
- K152341ViSi Mobile Monitoring System2Cleared 510(K)
- K150869Checkme Pro Health Monitor2Cleared 510(K)
- K151715T3 Software2Cleared 510(K)
- K152124Tempus IC22Cleared 510(K)
- K151071SmartLinx Vitals Plus Patient Monitoring System2Cleared 510(K)
- K150512STAR 902Cleared 510(K)
- K143304Sickbay Clinical Platform2Cleared 510(K)
- K150691Datalys Multi-Parameter Patient Monitor2Cleared 510(K)
- K150620740 SELECT2Cleared 510(K)
- K142032MRI PATIENT MONITORING SYSTEM TESLA M32Cleared 510(K)
- K142087COVA MONITORING SYSTEM2Cleared 510(K)
- K150361ViSi Mobile Monitoring System2Cleared 510(K)
- K143372AWARE2Cleared 510(K)
- K142732T3 Software2Cleared 510(K)
- K142244CLEO PATIENT MONITOR2Cleared 510(K)
- K143751Visi Mobile Monitoring System2Cleared 510(K)
- K142106DECISIO HEALTH PATIENT DASHBOARD2Cleared 510(K)
- K142840Unity Network ID2Cleared 510(K)
- K142356Connex Spot Monitor,901058 Vital Signs Monitor Core2Cleared 510(K)
- K142394Masimo Root Monitoring System and Accesories2Cleared 510(K)
- K133810VC150 VITAL SIGNS MONITOR2Cleared 510(K)
- K134014TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)2Cleared 510(K)
- K140188MASIMO ROOT MONITORING SYSTEM2Cleared 510(K)
- K140430740 SELECT2Cleared 510(K)
- K131762HANDHELD MONITOR2Cleared 510(K)
- K133988TEMPUS PRO EXTENDED FEATURES2Cleared 510(K)
- K132037VITAL SIGNS MONITOR2Cleared 510(K)
- K132038ACCUTORR 7 VITAL SIGNS MONITOR2Cleared 510(K)
- K140339VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM2Cleared 510(K)
- K132229OMNI PATENT MONITORS2Cleared 510(K)
- K131898A SERIES AND Q SERIES PATIENT MONITORS2Cleared 510(K)
- K133450AIRSTRIP REMOTE PATIENT MONITORING2Cleared 510(K)
- K133394AIRSTRIP REMOTE PATIENT MONITORING2Cleared 510(K)
- K132807MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)2Cleared 510(K)
- K133586VISI MOBILE MONITIORING SYSTEM2Cleared 510(K)
- K131497MCKESSON CARDIOLOGY HEMO2Cleared 510(K)
- K132604VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM2Cleared 510(K)
- K132033BM3/BM3 PLUS2Cleared 510(K)
- K132808VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR2Cleared 510(K)
- K130709VISI MOBILE MONITORING SYSTEM2Cleared 510(K)
- K123711PATIENT MONITOR2Cleared 510(K)
- K132359MRI PATIENT MONITORING SYSTEM2Cleared 510(K)
- K130740NIGHTINGALE MONITORING SYSTEM2Cleared 510(K)
- K131382EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL2Cleared 510(K)
- K131786AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER2Cleared 510(K)
- K124038BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)2Cleared 510(K)
- K130773TEMPUS PRO PATIENT MONITOR2Cleared 510(K)
- K130411740 SELECT2Cleared 510(K)
- K130796VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM2Cleared 510(K)
- K130957WVSM (WIRLESS VITAL SIGNS MONITOR)2Cleared 510(K)
- K130056PATIENT MONITOR2Cleared 510(K)
- K130234NUVON VITALS CHARTING SYSTEM2Cleared 510(K)
- K123002VITAL SYNC SYSTEM2Cleared 510(K)
- K124061MRI PATIENT MONITORING SYSTEM (MODEL 865214)2Cleared 510(K)
- K112877COMEN MULTI-PARAMETER PATIENT MONITOR2Cleared 510(K)
- K122133AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING2Cleared 510(K)
- K122036VISI MOBILE MONITORING SYSTEM2Cleared 510(K)
- K121013CONNEX VITAL SIGNS MONITOR 6000 SERIES2Cleared 510(K)
- K121871AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING2Cleared 510(K)
- K120193ANY VIEW PATIENT MONITORS2Cleared 510(K)
- K113835DATACAPTOR SYSTEM2Cleared 510(K)
- K121424EXPRESSION INFORMATION PORTAL2Cleared 510(K)
- K113833VITAL SIGNS MONITOR2Cleared 510(K)
- K112478VISI MOBILE MONITORING SYSTEM2Cleared 510(K)
- K120343CONNEX WORKSTATION2Cleared 510(K)
- K113183PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 5002Cleared 510(K)
- K113165MINI-MEDIC2Cleared 510(K)
- K113105TEMPUSIC PATIENT MONITOR2Cleared 510(K)
- K112687CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES2Cleared 510(K)
- K110463PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)2Cleared 510(K)
- K112329OMNI PATIENT MONITOR2Cleared 510(K)
- K112235AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING2Cleared 510(K)
- K103737OMNI II PATIENT MONITOR2Cleared 510(K)
- K110516CONNEX VITAL SIGNS MONITOR 6000 SERIES2Cleared 510(K)
- K100424DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS2Cleared 510(K)
- K103686STAR 50 N2Cleared 510(K)
- K103763STELLAR 3002Cleared 510(K)
- K110503AIRSTRIP REMOTE PATIENT MONITORING (RPM)2Cleared 510(K)
- K103432UNITY NETWORK ID2Cleared 510(K)
- K102579HYPERQ AD-100 SYSTEM2Cleared 510(K)
- K103268OMNI EXPRESS2Cleared 510(K)
- K101571XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS2Cleared 510(K)
- K102135VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM2Cleared 510(K)
- K102426CARESCAPE MODEL V100 VITAL SIGNS MONITOR2Cleared 510(K)
- K101052OMNI III PATIENT MONITOR2Cleared 510(K)
- K100133AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.12Cleared 510(K)
- K101674WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.02Cleared 510(K)
- K100740MD2000B VITAL SIGN MONITOR, MODEL MD2000B2Cleared 510(K)
- K101259V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-80022Cleared 510(K)
- K101127PATIENT MONITOR, MODEL PM502Cleared 510(K)
- K101445VITAL SIGNS MONITOR-VSM 6000 SERIES2Cleared 510(K)
- K101264TEMPUS IC PROFESSIONAL PATIENT MONITOR2Cleared 510(K)
- K093422VITAL SYNC MODEL 5000 SERIES2Cleared 510(K)
- K093017STELLAR 3002Cleared 510(K)
- K100394MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A2Cleared 510(K)
- K093177INTELLIBRIDGE SYSTEM2Cleared 510(K)
- K090785MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 8652142Cleared 510(K)
- K092153SKYLINE 55, MODEL VER 12Cleared 510(K)
- K083229E.S TECK ( ELECTRO SENSOR TECK)2Cleared 510(K)
- K082887PM-1000F+PATIENT MONITOR2Cleared 510(K)
- K082787VITAL SIGNS MONITOR, MODEL: MD500B2Cleared 510(K)
- K082008BIONET BM3PLUS PATIENT MONITOR2Cleared 510(K)
- K082812OMRON MODEL HBP-2070 VITAL SIGNS MONITOR2Cleared 510(K)
- K082564HYPERQ SYSTEM2Cleared 510(K)
- K082685GALAXY 552Cleared 510(K)
- K082256LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE2Cleared 510(K)
- K081552SKYLINE 552Cleared 510(K)
- K080141PC ECG 1200W SYSTEM2Cleared 510(K)
- K080173STAR 552Cleared 510(K)
- K073094VITALLINK3 MOBILE VITAL SIGNS SYSTEM2Cleared 510(K)
- K071802TESLA GUARD, MODEL EFT G042Cleared 510(K)
- K072516MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR2Cleared 510(K)
- K071982MODIFICATION TO: UNITY NETWORK ID2Cleared 510(K)
- K071472PLANET 552Cleared 510(K)
- K072389MODIFICATION TO HYPERQ SYSTEM2Cleared 510(K)
- K071606BIOSIGN CENTRAL STATION2Cleared 510(K)
- K071645MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S2Cleared 510(K)
- K070624HYPERQ SYSTEM2Cleared 510(K)
- K063840XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION2Cleared 510(K)
- K063547CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM2Cleared 510(K)
- K063055VS-800 VITAL SIGNS MONITOR2Cleared 510(K)
- K063087MODIFICATION TO MODEL 750 SERIES MONITOR2Cleared 510(K)
- K063419MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )2Cleared 510(K)
- K060756MEDLOG, MODEL 1-0-102Cleared 510(K)
- K061816GALAXY2Cleared 510(K)
- K061590SMDIE DEVICE INTERFACING SYSTEM2Cleared 510(K)
- K053193PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS2Cleared 510(K)
- K053234PM-9000 EXPRESS PATIENT MONITOR2Cleared 510(K)
- K060712VITELCARE C-TURTLE PATIENT MONITORING SYSTEM2Cleared 510(K)
- K053112BIOSIGN2Cleared 510(K)
- K060058STELLAR 404T2Cleared 510(K)
- K0534623160 MRI PATIENT MONITORING SYSTEM2Cleared 510(K)
- K052119TESLAGUARD, MODEL EFT G042Cleared 510(K)
- K051896MODEL 750E SERIES MONITOR2Cleared 510(K)
- K053027VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)2Cleared 510(K)
- K050399MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 31602Cleared 510(K)
- K051897TRIO MONITOR2Cleared 510(K)
- K051518UNITY NETWORK ID2Cleared 510(K)
- K051608STAR 50 MONITORING SYSTEM2Cleared 510(K)
- K042981HYPERQ SYSTEM2Cleared 510(K)
- K043370PLANET 50 MONITORING SYSTEM2Cleared 510(K)
- K043368VITELCARE TURTLE, MODEL 4002Cleared 510(K)
- K043348MODIFICATION TO PM-8000 PATIENT MONITOR2Cleared 510(K)
- K041918INTEGRATED PATIENT MONITORING SYSTEM2Cleared 510(K)
- K042560STELLAR 404 MONITORING SYSTEM2Cleared 510(K)
- K0425698600 VITAL SIGNS MONITOR2Cleared 510(K)
- K040915MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M2Cleared 510(K)
- K041942M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K041907TRIO MONITOR2Cleared 510(K)
- K041376C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A2Cleared 510(K)
- K040969POISE DATAENGINE2Cleared 510(K)
- K041401MODIFICATION TO M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K040559MODIFICATION TO UNITY NETWORK ID2Cleared 510(K)
- K033133TELECARE D.R. SERVER SOFTWARE SYSTEM2Cleared 510(K)
- K033378VITAL SIGNS MONITOR, PROPAQ LT2Cleared 510(K)
- K033988GOLDWAY UT4000A VITAL SIGNS MONITOR2Cleared 510(K)
- K033030CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM2Cleared 510(K)
- K032338TRIO MONITOR MODEL 0998-00-06002Cleared 510(K)
- K033672MODIFICATION TO UNITY NETWORK ID2Cleared 510(K)
- K033680M2376A PHILIPS DEVICE LINK SYSTEM2Cleared 510(K)
- K032871PLANET MONITORING SYSTEM2Cleared 510(K)
- K032867STAR (LUNAR SERIES) MONITORING SYSTEM2Cleared 510(K)
- K030419VITERION 100 TELEHEALTH MONITOR2Cleared 510(K)
- K033283CENTRA VIEW DEVICE LINK SYSTEM2Cleared 510(K)
- K031863CARESTATION 126S VIDEOPHONE2Cleared 510(K)
- K032749BEDSIDE MONITOR, MODEL OPV-15002Cleared 510(K)
- K032142DATACAPTOR2Cleared 510(K)
- K023195MAGLIFE C/MAGLIFE C PLUS2Cleared 510(K)
- K021154GOLDWAY PATIENT MONITOR, MODEL # UT4000F2Cleared 510(K)
- K030731M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K021454UNITY NETWORK ID2Cleared 510(K)
- K022920M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K022537PRESS-MATE PM-2100 VITAL SIGN MONITOR2Cleared 510(K)
- K014255DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 4002Cleared 510(K)
- K021912M2376 DEVICELINK SYSTEM2Cleared 510(K)
- K021435DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N2Cleared 510(K)
- K021347MODIFICATION TO M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K020494MODIFICATION TO M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K020197MODIFICATION TO DATACAPTOR2Cleared 510(K)
- K020022DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 4102Cleared 510(K)
- K012349METAVISION CLINICAL INFORMATION SYSTEM2Cleared 510(K)
- K014181M2376A DEVICELINK SYSTEM, MODEL M2376A2Cleared 510(K)
- K013019DATACAPTOR2Cleared 510(K)
- K013470MODIFICATION TO M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K010732VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)2Cleared 510(K)
- K010424NEXAN SYSTEM, MODEL NX-3012Cleared 510(K)
- K0120598100/8500 VITAL SIGNS MONITOR2Cleared 510(K)
- K012094MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A2Cleared 510(K)
- K003999AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 10102Cleared 510(K)
- K010770BCI ADVISOR VITAL SIGNS MONITOR (9200)2Cleared 510(K)
- K011578M2376A DEVICELINK SYSTEM, MODEL M2376A2Cleared 510(K)
- K004050PANASONIC TELE-HOMECARE SYSTEM2Cleared 510(K)
- K010453M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K010342M2376A DEVICELINK SYSTEM, MODEL M2376A2Cleared 510(K)
- K010048M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K003622M2376A DEVICELINK SYSTEM, MODEL M2376A2Cleared 510(K)
- K000404PC ECG 12002Cleared 510(K)
- K003107M2376A DEVICELINK SYSTEM2Cleared 510(K)
- K002967M2376A DEVICELINK SYSTEM, MODEL M2376A2Cleared 510(K)
- K002030OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES2Cleared 510(K)
- K002009HP M2376A DEVICE LINK SYSTEM, MODEL M2376A2Cleared 510(K)
- K001265WELCH ALLYN INSTRUMENT INTERFACE MODULE2Cleared 510(K)
- K001776MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A2Cleared 510(K)
- K0010208100 VITAL SIGNS MONITOR2Cleared 510(K)
- K000635MODIFICATION TO HP M2376A DEVICE LINK SYSTEM2Cleared 510(K)
- K992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 4002Cleared 510(K)
- K983928KODAK HOME HEALTH MONITORING SYSTEM2Cleared 510(K)
- K980688INTEGRITI PATIENT MONITOR2Cleared 510(K)
- MWJElectrocardiograph, Ambulatory (Without Analysis)2Product Code
- MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)2Product Code
- NMDOximeter, Tissue Saturation, Reprocessed2Product Code
- NQHSensor, Pressure, Aneurysm, Implantable2Product Code
- OCHOximeter, Infrared, Sporting, Aviation2Product Code
- OEYSingle Lead Over-The-Counter Electrocardiograph2Product Code
- QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate2Product Code
- OFILaser Blood Flow Kit2Product Code
- PFYLow Patient Acuity Monitoring System2Product Code
- PLBMultivariate Vital Signs Index2Product Code
- PPWAdjunctive Cardiovascular Status Indicator2Product Code
- QAQAdjunctive Predictive Cardiovascular Indicator2Product Code
- QDAElectrocardiograph Software For Over-The-Counter Use2Product Code
- QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use2Product Code
- QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator2Product Code
- QNVAdjunctive Hemodynamic Indicator With Decision Point2Product Code
- QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate2Product Code
- QUOAdjunctive Heart Failure Status Indicator2Product Code
- QXZAdjunctive Epicardial Vascular Physiologic Status Indicator2Product Code
- SARAdjunctive Hemodynamic Indicator With Decision Point For Military Use2Product Code
- SDJAdjunctive Cardiac Amyloidosis Status Indicator2Product Code
- SDYLoss Of Pulse Notification Software2Product Code
- 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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Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230457
- 510(k) Type
- Traditional
- Applicant
- Empatica S.r.l.
- Country
- Italy
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/30/2023
- Days to Decision
- 251 days
- Submission Type
- Summary