510(k) Report

Devices descending from K982135

288 later devices reach Oscillomate Ems Nibp Monitor Model 9001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+1K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc.20041—
+1K990338Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemPhysio-Control Corp.1999121
+2K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+2K130411740 SelectCas Medical Systems, Inc.20136—
+2K102972Lifepak 12Physio-Control, Inc.201001
+2K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.200953
+2K071164Life+Cel BatteryAmco International Manufacturing & Design, Inc.20070—
+2K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group20072—
+2K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.200772
+2K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc.2005264—
+2K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.20049—
+2K040775Lifepak 12Medtronic Physio-Control Corp.2004101
+2K030898Mobile Battery Service Station (MBSS)Ad Elektronik GmbH20030—
+3K200160740 SafeSATZoe Medical, Inc.20210—
+3K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+3K161909IQvitals ZoneMidmark Corporation201614
+3K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.20142Class I
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc.20130Class I
+3K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.20114—
+3K062331Highpak-12Ad Elektronik GmbH20070—
+3K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+3K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+4K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+4K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control20241—
+4K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+4K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+4K160582WiCapAthena Gtx20160—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+4K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+4K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+4K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+4K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+4K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+4K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+4K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+5K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+5K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.20250—
+5K242798AirmodHeroic Faith International, Ltd.20251—
+5K170820Capnograph and OximeterCmi Health, Inc.20181—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+5K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+5K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+5K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+5K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+5K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+5K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+6K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+6K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+6K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+6K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+6K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+6K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+6K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+6K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K231625VitalDetectWellvii, Inc.20240—
+7K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+7K220111RespiraSensePmd Solutions20221—
+7K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+7K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+7K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+7K192514Patient MonitorEdan Instruments, Inc.202061