510(k) Report

Devices descending from K910772

435 later devices reach Propaq 102, 104 and 106 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K120052CvinsightIntelomed, Inc.20120—
+7K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+7K120173Patient MonitorEdan Instruments, Inc.201210—
+7K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+7K113653Patient MonitorEdan Instruments, Inc.201212
+7K113623Patient MonitorEdan Instruments, Inc.2012152
+7K111922Vocare Myhealth TabletVocare, Inc.20110—
+7K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+7K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+7K110922Patient MonitorEdan Instruments, Inc.201111
+7K110334Waldo Patient MonitorWaldo Health20111—
+7K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+7K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+7K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+7K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+7K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+7K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+7K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+7K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+7K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+7K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+7K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+7K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+7K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+7K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+7K063814BP-200 PlusSchiller AG20077—
+7K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+8K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+8K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+8K242290DormoTech NLabDormotech Medical, Ltd.20250—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+8K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+8K222597BabySat 3Owlet Babycare, Inc.20230—
+8K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+8K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+8K200537OxxiomTrue Wearables, Inc.20200—
+8K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+8K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+8K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+8K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+8K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+8K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+8K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+8K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+8K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+8K160981Patient MonitorEdan Instruments, Inc.201681
+8K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+8K152043Diagnostic Station DS20Schiller AG20161—
+8K152831Spot SkanSkanray Technologies Private Limited20160—
+8K151512Star 60Skanray Technologies Private Limited20160—
+8K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+8K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+8K143272ApneaLink AirResmed Germany, Inc.20157—
+8K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+8K133997LG SmarthealthLg Electronics20140—
+8K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+8K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+8K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+8K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+8K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+8K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+8K131379EarlysenseEarlysense, Ltd.20137—
+8K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+8K132148S HealthSamsung Electronics Co., Ltd.20130—
+8K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+8K131021Pulse OximeterNonin Medical, Inc.20133—
+8K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+8K124062QDC-Pro, and Nox-RipNox Medical20133—
+8K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+8K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+8K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+8K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+8K122333Mobilecare MonitorAframe Digital, Inc.20120—
+8K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+8K122285Tablet CommanderCardiocom, LLC20125—
+8K121617SensicardiacDiacoustic Medical (Pty)201210—
+8K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+8K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+8K120631Patient MonitorAdvanced Instruments, Inc.20120—
+8K113865PultolSharp Corporation20120—
+8K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+8K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+8K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+8K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+8K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+8K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+8K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+8K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+9K253436c-med0 alphaCosinuss GmbH20260—
+9K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—
+9K233827OxiWearOxiwear, Inc.20240—
+9K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+9K231625VitalDetectWellvii, Inc.20240—
+9K223721Masimo StorkMasimo Corporation20230—
+9K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+9K220111RespiraSensePmd Solutions20221—