510(k) Report

Devices descending from K893221

431 later devices reach Model 8500 Hand Held Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982969Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847Nonin Medical, Inc.19990—
+1K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc.1998425—
+1K980879Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc.1998426—
+1K980299Apex OximeterMarquette Medical Systems, Inc.199821
+2K080251Apexpro Telemetry SystemsGe Medical Systems Information Technologies200814
+2K063137Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000Pharmasmart, Inc.20075—
+2K061256Smartmonitor 2PSRespironics, Inc.200603
+2K051907InnocorInnovision A/S20064—
+2K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+2K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd.200339—
+2K020440NewcorSiemens Medical Systems, Inc.2002910
+2K013319Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) MonitorNonin Medical, Inc.2002124—
+3K190561NICU V'02Cosmed Nordic Aps20200—
+3K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+3K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc.201601
+3K140360Health KioskEngagementhealth, LLC20150—
+3K131812Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc.20132—
+3K130411740 SelectCas Medical Systems, Inc.20136—
+3K102047Lci Option for InnocorInnovision A/S201101
+3K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+3K093389Csi Model 5K Managed Health System KioskComputerized Screening, Inc.20093—
+3K090801Electronic House CallExpress MD Solutions, LLC20093—
+3K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+3K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group20072—
+3K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+3K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc.2005264—
+3K041308Remotenurse Patient Monitoring SystemWebvmc, LLC200434—
+3K041156Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc.2004891
+3K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc.200442—
+4K200160740 SafeSATZoe Medical, Inc.20210—
+4K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+4K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+4K161909IQvitals ZoneMidmark Corporation201614
+4K150493SensisSiemens Medi Cal Solutions, Inc.2015111
+4K140430740 SelectCas Medical Systems, Inc.20141—
+4K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+4K113402Solohealth StationSolohealth, Inc.20120—
+4K102063Health-E-Connect SystemAlr Technologies20111—
+4K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc.20101—
+4K093895Ally Platform SystemContinuity Health Solutions20100—
+4K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+4K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+4K063008Health Check KioskXperex Corporation20074—
+4K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+4K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+4K052669Avant Digital Pulse Oximetry System, Model 4000, 4100Nonin Medical, Inc.200511—
+4K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+4K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc.20057—
+4K0433594100 Patient Oximeter ModuleNonin Medical, Inc.200575—
+4K043162PMP4 Oxy ProCard Guard Scientific Survival, Ltd.20040—
+4K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+5K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+5K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+5K233446AMC Health CareConsoleAmc Health20240—
+5K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+5K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+5K191574OxSAT 100S.L.P., Ltd.20200—
+5K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+5K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+5K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+5K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+5K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+5K163664Health-e-Connect System with IDAAlr Technologies20170—
+5K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+5K153600Consult Station TSH4D Sas20170—
+5K162580Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20172—
+5K151839AMC Health VitalCaregiving SystemAmc Health20161—
+5K160582WiCapAthena Gtx20160—
+5K150620740 SelectCas Medical Systems, Inc.201501
+5K143108HealthGuard-15Futrex, Inc.20150—
+5K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+5K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+5K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+5K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+5K120052CvinsightIntelomed, Inc.20120—
+5K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+5K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+5K111922Vocare Myhealth TabletVocare, Inc.20110—
+5K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+5K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+5K110334Waldo Patient MonitorWaldo Health20111—
+5K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+5K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+5K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+5K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+5K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+5K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+5K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+5K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+5K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+5K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+5K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+5K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+5K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+5K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+5K063814BP-200 PlusSchiller AG20077—
+5K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+5K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+6K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+6K242798AirmodHeroic Faith International, Ltd.20251—