510(k) Report

Devices descending from K982776

425 later devices reach 9303 Neonatal/Adult Vital Signs Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063137Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000Pharmasmart, Inc.20075—
+1K061256Smartmonitor 2PSRespironics, Inc.200603
+1K051907InnocorInnovision A/S20064—
+1K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+1K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd.200339—
+1K020440NewcorSiemens Medical Systems, Inc.2002910
+1K013319Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) MonitorNonin Medical, Inc.2002124—
+2K190561NICU V'02Cosmed Nordic Aps20200—
+2K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+2K140360Health KioskEngagementhealth, LLC20150—
+2K131812Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc.20132—
+2K130411740 SelectCas Medical Systems, Inc.20136—
+2K102047Lci Option for InnocorInnovision A/S201101
+2K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+2K093389Csi Model 5K Managed Health System KioskComputerized Screening, Inc.20093—
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+2K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group20072—
+2K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+2K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc.2005264—
+2K041308Remotenurse Patient Monitoring SystemWebvmc, LLC200434—
+2K041156Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc.2004891
+2K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc.200442—
+3K200160740 SafeSATZoe Medical, Inc.20210—
+3K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+3K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+3K161909IQvitals ZoneMidmark Corporation201614
+3K150493SensisSiemens Medi Cal Solutions, Inc.2015111
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+3K113402Solohealth StationSolohealth, Inc.20120—
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc.20101—
+3K093895Ally Platform SystemContinuity Health Solutions20100—
+3K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+3K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+3K063008Health Check KioskXperex Corporation20074—
+3K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+3K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+3K052669Avant Digital Pulse Oximetry System, Model 4000, 4100Nonin Medical, Inc.200511—
+3K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+3K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc.20057—
+3K0433594100 Patient Oximeter ModuleNonin Medical, Inc.200575—
+3K043162PMP4 Oxy ProCard Guard Scientific Survival, Ltd.20040—
+3K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+4K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+4K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+4K233446AMC Health CareConsoleAmc Health20240—
+4K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+4K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+4K191574OxSAT 100S.L.P., Ltd.20200—
+4K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+4K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+4K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+4K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+4K153600Consult Station TSH4D Sas20170—
+4K162580Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20172—
+4K151839AMC Health VitalCaregiving SystemAmc Health20161—
+4K160582WiCapAthena Gtx20160—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K143108HealthGuard-15Futrex, Inc.20150—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+4K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+4K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+4K120052CvinsightIntelomed, Inc.20120—
+4K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+4K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+4K111922Vocare Myhealth TabletVocare, Inc.20110—
+4K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+4K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+4K110334Waldo Patient MonitorWaldo Health20111—
+4K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+4K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+4K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+4K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+4K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+4K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+4K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+4K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+4K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+4K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+4K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+4K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+4K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+4K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+4K063814BP-200 PlusSchiller AG20077—
+4K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+4K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+5K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+5K242798AirmodHeroic Faith International, Ltd.20251—
+5K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K242290DormoTech NLabDormotech Medical, Ltd.20250—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K222597BabySat 3Owlet Babycare, Inc.20230—