510(k) Report

Devices descending from K980879

426 later devices reach Oscillomate Nibp / SP02 Ems Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+5K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+5K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+5K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+5K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+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—
+5K063814BP-200 PlusSchiller AG20077—
+5K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+6K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+6K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+6K242290DormoTech NLabDormotech Medical, Ltd.20250—
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K222597BabySat 3Owlet Babycare, Inc.20230—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+6K200537OxxiomTrue Wearables, Inc.20200—
+6K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+6K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K152831Spot SkanSkanray Technologies Private Limited20160—
+6K151512Star 60Skanray Technologies Private Limited20160—
+6K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+6K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+6K143272ApneaLink AirResmed Germany, Inc.20157—
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K133997LG SmarthealthLg Electronics20140—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+6K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+6K131379EarlysenseEarlysense, Ltd.20137—
+6K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+6K132148S HealthSamsung Electronics Co., Ltd.20130—
+6K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+6K131021Pulse OximeterNonin Medical, Inc.20133—
+6K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+6K124062QDC-Pro, and Nox-RipNox Medical20133—
+6K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+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—
+6K122333Mobilecare MonitorAframe Digital, Inc.20120—
+6K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+6K122285Tablet CommanderCardiocom, LLC20125—
+6K121617SensicardiacDiacoustic Medical (Pty)201210—
+6K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+6K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K113865PultolSharp Corporation20120—
+6K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+6K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+6K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+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—
+6K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+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—
+7K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+7K233827OxiWearOxiwear, Inc.20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K231625VitalDetectWellvii, Inc.20240—
+7K223721Masimo StorkMasimo Corporation20230—
+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
+7K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+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
+7K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+7K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+7K192514Patient MonitorEdan Instruments, Inc.202061
+7K191403Pulse OximeterNonin Medical, Inc.20191—
+7K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+7K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+7K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+7K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+7K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+7K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—