BEUDAMED
    Product Code: MWI FDA class 2 21 CFR 870.2300

    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    Cardiovascular

    A Physiological Patient Monitor Without Arrhythmia Detection or Alarms is a device that continuously measures and displays one or more physiological parameters (such as heart rate, blood pressure, or respiration) without automated arrhythmia recognition or alarm capabilities, used for basic patient surveillance in lower-acuity settings. It is FDA Class 2, requiring 510(k) clearance, with product code MWI under 21 CFR 870.2300 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    302
    FEI Numbers
    170
    Registration Numbers
    170
    Unique Applicants
    158
    Years Active
    26

    Basic Information

    Product Code
    MWI
    Device Class
    FDA class 2
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 302 510(k) clearances via K numbers.

    K Number Device Name
    K242737 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
    K241958 WARD-CSS (v1.2.x)
    K243146 iCare APP
    K241411 Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
    K243216 Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
    K233446 AMC Health CareConsole
    K240236 Happy Ring Health Monitoring System
    K233354 WVSM Pro (Series) (500-0030-XX)
    K232111 NeoBeat, NeoBeat Mini
    K233810 Portrait VSM
    K233133 Talis EMR with Talis +ACG (Talis EMR with +ACG)
    K234130 Portrait™ 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 O
    K233038 Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
    K231086 CPM System
    K230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
    K230881 Change Healthcare Cardiology Hemodynamics™
    K230626 Portrait™ 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™
    K220117 ARC Intensive Care Information System (ARC System)
    K230214 Huma RPM (RPM)
    K222330 The Heart Seat
    K212161 Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
    K221267 VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
    K221113 Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
    K212473 Welch Allyn Connex Central Station
    K212975 MedWand
    K213335 Capsule Surveillance System
    K211754 Vital Signs Monitor
    K210204 Capsule Vitals Plus Patient Monitoring System
    K211475 Vital Signs Monitors
    K212227 Philips MR Patient Care Portal
    K210086 Vitals360 Multi-Vitals Mobile Monitor
    K202375 ZOLL Propaq M
    K200160 740 SafeSAT
    K201635 MouthLab Vital Signs Monitoring System
    K202892 Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
    K202306 T3 Platform software
    K193626 Masimo Rad-97 Pulse CO-Oximeter and Accessories
    K200856 SmartLinx Vitals Plus Patient Monitoring System
    K200141 Oxi-W System
    K191882 Masimo Centroid System
    K193242 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
    K191989 WVSM (Wireless Vital Signs Monitor) RWC + miniCap
    K192004 Eko Analysis Software
    K191059 Masimo Rad-97 and Accessories
    K190273 T3 Platform software
    K183687 LifeWindow LW8 Lite
    K183370 PeraMobile and PeraWatch
    K182401 B.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 meter
    K190090 DynoSense Vital Sign Measuring System
    K190468 Nihon Kohden SVM-7200 Series Vital Signs Monitor
    K183697 Masimo Rad-97 and Accessories
    K183638 SmartLinx Vitals Plus Patient Monitoring System
    K183634 Stasis Monitoring System
    K181541 Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
    K181919 Patient Monitor
    K180903 3880 MRI Patient Monitoring System
    K182821 Accutorr 7/VS-900/VS-900c Vital Signs Monitor
    K172965 Handheld VitalSigns Monitoring System
    K182900 3880 MRI Patient Monitoring System
    K183116 Unity Network ID
    K182226 AirStrip RPM InvisionHeart Adapter
    K181311 Philips Hemodynamic Application R1.0
    K180734 SmartLinx Vitals Plus Patient Monitoring System
    K172221 VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100
    K172147 STAR 65
    K172959 PeraServer and PeraTrend
    K171361 BETTERCARE PLATFORM - ADVANCED WEB CLIENT
    K171056 WAVE Clinical Platform
    K171121 Masimo Root Monitoring System and Accessories
    K172200 3880 MRI Patient Monitoring System
    K171751 SmartLinx 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 Module
    K170538 RVS-100 Vital Signs Monitor
    K170168 Masimo Rad-97 and Accessories
    K170047 All-in-One Health Monitor, PC-303
    K170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
    K170712 Accutorr 7/VS-900 Vital Signs Monitor
    K170798 Dictum Health
    K160899 CoVa Monitoring System 2
    K163065 T3 Software
    K170199 Unity Network ID
    K162234 Truscope Ultra Patient Monitor
    K161909 IQvitals Zone
    K160718 Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
    K151839 AMC Health VitalCaregiving System
    K160956 LD-Oxi system
    K153739 MRI Patient Monitor TeslaDUO
    K153225 Masimo Root Monitoring System and Accessories
    K153079 Axeo 3 Patient Monitor
    K153335 AlertWatch: OR
    K153135 VITAL SIGNS MONITOR
    K151512 Star 60
    K151644 Masimo Root Vital Signs Monitoring System and Accessories
    K152645 Dictum Health
    K152330 Expression MR400 MRI Patient Monitoring System
    K152341 ViSi Mobile Monitoring System
    K150869 Checkme Pro Health Monitor
    K151715 T3 Software
    K152124 Tempus IC2
    K151071 SmartLinx Vitals Plus Patient Monitoring System
    K150512 STAR 90
    K143304 Sickbay Clinical Platform
    K150691 Datalys Multi-Parameter Patient Monitor
    K150620 740 SELECT
    K142032 MRI PATIENT MONITORING SYSTEM TESLA M3
    K142087 COVA MONITORING SYSTEM
    K150361 ViSi Mobile Monitoring System
    K143372 AWARE
    K142732 T3 Software
    K142244 CLEO PATIENT MONITOR
    K143751 Visi Mobile Monitoring System
    K142106 DECISIO HEALTH PATIENT DASHBOARD
    K142840 Unity Network ID
    K142356 Connex Spot Monitor,901058 Vital Signs Monitor Core
    K142394 Masimo Root Monitoring System and Accesories
    K133810 VC150 VITAL SIGNS MONITOR
    K134014 TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
    K140188 MASIMO ROOT MONITORING SYSTEM
    K140430 740 SELECT
    K131762 HANDHELD MONITOR
    K133988 TEMPUS PRO EXTENDED FEATURES
    K132037 VITAL SIGNS MONITOR
    K132038 ACCUTORR 7 VITAL SIGNS MONITOR
    K140339 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
    K132229 OMNI PATENT MONITORS
    K131898 A SERIES AND Q SERIES PATIENT MONITORS
    K133450 AIRSTRIP REMOTE PATIENT MONITORING
    K133394 AIRSTRIP REMOTE PATIENT MONITORING
    K132807 MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
    K133586 VISI MOBILE MONITIORING SYSTEM
    K131497 MCKESSON CARDIOLOGY HEMO
    K132604 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
    K132033 BM3/BM3 PLUS
    K132808 VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
    K130709 VISI MOBILE MONITORING SYSTEM
    K123711 PATIENT MONITOR
    K132359 MRI PATIENT MONITORING SYSTEM
    K130740 NIGHTINGALE MONITORING SYSTEM
    K131382 EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
    K131786 AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
    K124038 BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
    K130773 TEMPUS PRO PATIENT MONITOR
    K130411 740 SELECT
    K130796 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
    K130957 WVSM (WIRLESS VITAL SIGNS MONITOR)
    K130056 PATIENT MONITOR
    K130234 NUVON VITALS CHARTING SYSTEM
    K123002 VITAL SYNC SYSTEM
    K124061 MRI PATIENT MONITORING SYSTEM (MODEL 865214)
    K112877 COMEN MULTI-PARAMETER PATIENT MONITOR
    K122133 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    K122036 VISI MOBILE MONITORING SYSTEM
    K121013 CONNEX VITAL SIGNS MONITOR 6000 SERIES
    K121871 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    K120193 ANY VIEW PATIENT MONITORS
    K113835 DATACAPTOR SYSTEM
    K121424 EXPRESSION INFORMATION PORTAL
    K113833 VITAL SIGNS MONITOR
    K112478 VISI MOBILE MONITORING SYSTEM
    K120343 CONNEX WORKSTATION
    K113183 PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
    K113165 MINI-MEDIC
    K113105 TEMPUSIC PATIENT MONITOR
    K112687 CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
    K110463 PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
    K112329 OMNI PATIENT MONITOR
    K112235 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    K103737 OMNI II PATIENT MONITOR
    K110516 CONNEX VITAL SIGNS MONITOR 6000 SERIES
    K100424 DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS
    K103686 STAR 50 N
    K103763 STELLAR 300
    K110503 AIRSTRIP REMOTE PATIENT MONITORING (RPM)
    K103432 UNITY NETWORK ID
    K102579 HYPERQ AD-100 SYSTEM
    K103268 OMNI EXPRESS
    K101571 XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
    K102135 VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM
    K102426 CARESCAPE MODEL V100 VITAL SIGNS MONITOR
    K101052 OMNI III PATIENT MONITOR
    K100133 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
    K101674 WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0
    K100740 MD2000B VITAL SIGN MONITOR, MODEL MD2000B
    K101259 V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
    K101127 PATIENT MONITOR, MODEL PM50
    K101445 VITAL SIGNS MONITOR-VSM 6000 SERIES
    K101264 TEMPUS IC PROFESSIONAL PATIENT MONITOR
    K093422 VITAL SYNC MODEL 5000 SERIES
    K093017 STELLAR 300
    K100394 MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A
    K093177 INTELLIBRIDGE SYSTEM
    K090785 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
    K092153 SKYLINE 55, MODEL VER 1
    K083229 E.S TECK ( ELECTRO SENSOR TECK)
    K082887 PM-1000F+PATIENT MONITOR
    K082787 VITAL SIGNS MONITOR, MODEL: MD500B
    K082008 BIONET BM3PLUS PATIENT MONITOR
    K082812 OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
    K082564 HYPERQ SYSTEM
    K082685 GALAXY 55
    K082256 LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE
    K081552 SKYLINE 55
    K080141 PC ECG 1200W SYSTEM
    K080173 STAR 55
    K073094 VITALLINK3 MOBILE VITAL SIGNS SYSTEM
    K071802 TESLA GUARD, MODEL EFT G04
    K072516 MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR
    K071982 MODIFICATION TO: UNITY NETWORK ID
    K071472 PLANET 55
    K072389 MODIFICATION TO HYPERQ SYSTEM
    K071606 BIOSIGN CENTRAL STATION
    K071645 MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
    K070624 HYPERQ SYSTEM
    K063840 XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION
    K063547 CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
    K063055 VS-800 VITAL SIGNS MONITOR
    K063087 MODIFICATION TO MODEL 750 SERIES MONITOR
    K063419 MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
    K060756 MEDLOG, MODEL 1-0-10
    K061816 GALAXY
    K061590 SMDIE DEVICE INTERFACING SYSTEM
    K053193 PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
    K053234 PM-9000 EXPRESS PATIENT MONITOR
    K060712 VITELCARE C-TURTLE PATIENT MONITORING SYSTEM
    K053112 BIOSIGN
    K060058 STELLAR 404T
    K053462 3160 MRI PATIENT MONITORING SYSTEM
    K052119 TESLAGUARD, MODEL EFT G04
    K051896 MODEL 750E SERIES MONITOR
    K053027 VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
    K050399 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160
    K051897 TRIO MONITOR
    K051518 UNITY NETWORK ID
    K051608 STAR 50 MONITORING SYSTEM
    K042981 HYPERQ SYSTEM
    K043370 PLANET 50 MONITORING SYSTEM
    K043368 VITELCARE TURTLE, MODEL 400
    K043348 MODIFICATION TO PM-8000 PATIENT MONITOR
    K041918 INTEGRATED PATIENT MONITORING SYSTEM
    K042560 STELLAR 404 MONITORING SYSTEM
    K042569 8600 VITAL SIGNS MONITOR
    K040915 MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
    K041942 M2376A DEVICELINK SYSTEM
    K041907 TRIO MONITOR
    K041376 C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A
    K040969 POISE DATAENGINE
    K041401 MODIFICATION TO M2376A DEVICELINK SYSTEM
    K040559 MODIFICATION TO UNITY NETWORK ID
    K033133 TELECARE D.R. SERVER SOFTWARE SYSTEM
    K033378 VITAL SIGNS MONITOR, PROPAQ LT
    K033988 GOLDWAY UT4000A VITAL SIGNS MONITOR
    K033030 CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
    K032338 TRIO MONITOR MODEL 0998-00-0600
    K033672 MODIFICATION TO UNITY NETWORK ID
    K033680 M2376A PHILIPS DEVICE LINK SYSTEM
    K032871 PLANET MONITORING SYSTEM
    K032867 STAR (LUNAR SERIES) MONITORING SYSTEM
    K030419 VITERION 100 TELEHEALTH MONITOR
    K033283 CENTRA VIEW DEVICE LINK SYSTEM
    K031863 CARESTATION 126S VIDEOPHONE
    K032749 BEDSIDE MONITOR, MODEL OPV-1500
    K032142 DATACAPTOR
    K023195 MAGLIFE C/MAGLIFE C PLUS
    K021154 GOLDWAY PATIENT MONITOR, MODEL # UT4000F
    K030731 M2376A DEVICELINK SYSTEM
    K021454 UNITY NETWORK ID
    K022920 M2376A DEVICELINK SYSTEM
    K022537 PRESS-MATE PM-2100 VITAL SIGN MONITOR
    K014255 DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400
    K021912 M2376 DEVICELINK SYSTEM
    K021435 DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
    K021347 MODIFICATION TO M2376A DEVICELINK SYSTEM
    K020494 MODIFICATION TO M2376A DEVICELINK SYSTEM
    K020197 MODIFICATION TO DATACAPTOR
    K020022 DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
    K012349 METAVISION CLINICAL INFORMATION SYSTEM
    K014181 M2376A DEVICELINK SYSTEM, MODEL M2376A
    K013019 DATACAPTOR
    K013470 MODIFICATION TO M2376A DEVICELINK SYSTEM
    K010732 VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
    K010424 NEXAN SYSTEM, MODEL NX-301
    K012059 8100/8500 VITAL SIGNS MONITOR
    K012094 MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
    K003999 AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010
    K010770 BCI ADVISOR VITAL SIGNS MONITOR (9200)
    K011578 M2376A DEVICELINK SYSTEM, MODEL M2376A
    K004050 PANASONIC TELE-HOMECARE SYSTEM
    K010453 M2376A DEVICELINK SYSTEM
    K010342 M2376A DEVICELINK SYSTEM, MODEL M2376A
    K010048 M2376A DEVICELINK SYSTEM
    K003622 M2376A DEVICELINK SYSTEM, MODEL M2376A
    K000404 PC ECG 1200
    K003107 M2376A DEVICELINK SYSTEM
    K002967 M2376A DEVICELINK SYSTEM, MODEL M2376A
    K002030 OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
    K002009 HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
    K001265 WELCH ALLYN INSTRUMENT INTERFACE MODULE
    K001776 MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
    K001020 8100 VITAL SIGNS MONITOR
    K000635 MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
    K992638 DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
    K983928 KODAK HOME HEALTH MONITORING SYSTEM
    K980688 INTEGRITI PATIENT MONITOR

    FEI Numbers

    This FDA classification entry is associated with 170 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 170 registration numbers. Click on an entry to view related FDA registrations.