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
+5K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+5K200537OxxiomTrue Wearables, Inc.20200—
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+5K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+5K170820Capnograph and OximeterCmi Health, Inc.20181—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K152831Spot SkanSkanray Technologies Private Limited20160—
+5K151512Star 60Skanray Technologies Private Limited20160—
+5K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+5K143272ApneaLink AirResmed Germany, Inc.20157—
+5K133997LG SmarthealthLg Electronics20140—
+5K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+5K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+5K131379EarlysenseEarlysense, Ltd.20137—
+5K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+5K132148S HealthSamsung Electronics Co., Ltd.20130—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K131021Pulse OximeterNonin Medical, Inc.20133—
+5K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+5K124062QDC-Pro, and Nox-RipNox Medical20133—
+5K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+5K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+5K122333Mobilecare MonitorAframe Digital, Inc.20120—
+5K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+5K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+5K122285Tablet CommanderCardiocom, LLC20125—
+5K121617SensicardiacDiacoustic Medical (Pty)201210—
+5K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+5K113865PultolSharp Corporation20120—
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+5K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+5K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+5K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+5K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+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—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K233827OxiWearOxiwear, Inc.20240—
+6K223721Masimo StorkMasimo Corporation20230—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+6K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+6K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K191403Pulse OximeterNonin Medical, Inc.20191—
+6K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+6K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K170182Cardiovit FT-1Schiller AG20170—
+6K163665MATRx plusZephyr Sleep Technologies20173—
+6K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+6K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+6K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+6K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K140785Pulse OximeterNonin Medical, Inc.20140—
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+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
+6K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+6K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+6K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+6K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+6K131287CardiosleeveRijuven Corp20131—
+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
+6K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+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—
+7K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+7K253274BedDot (G1)Intelligent Dots, LLC20260—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—