510(k) Report

Devices descending from K970763

171 later devices reach Modular Telemetry System (MTS) Option for the Mde Escort II Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051907InnocorInnovision A/S20064—
+1K043354Modular Telemetry System for the Vision Telepak, Model 20701Invivo Research, Inc.20050—
+1K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd.200339—
+1K013319Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) MonitorNonin Medical, Inc.2002124—
+2K190561NICU V'02Cosmed Nordic Aps20200—
+2K102047Lci Option for InnocorInnovision A/S201101
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+2K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+2K041308Remotenurse Patient Monitoring SystemWebvmc, LLC200434—
+2K041156Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc.2004891
+2K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc.200442—
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K093895Ally Platform SystemContinuity Health Solutions20100—
+3K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+3K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+3K063008Health Check KioskXperex Corporation20074—
+3K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+3K052669Avant Digital Pulse Oximetry System, Model 4000, 4100Nonin Medical, Inc.200511—
+3K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc.20057—
+3K0433594100 Patient Oximeter ModuleNonin Medical, Inc.200575—
+3K043162PMP4 Oxy ProCard Guard Scientific Survival, Ltd.20040—
+3K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+4K233446AMC Health CareConsoleAmc Health20240—
+4K191574OxSAT 100S.L.P., Ltd.20200—
+4K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+4K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K162580Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20172—
+4K151839AMC Health VitalCaregiving SystemAmc Health20161—
+4K143108HealthGuard-15Futrex, Inc.20150—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+4K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+4K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+4K120052CvinsightIntelomed, Inc.20120—
+4K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+4K113402Solohealth StationSolohealth, Inc.20120—
+4K111922Vocare Myhealth TabletVocare, Inc.20110—
+4K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+4K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+4K110334Waldo Patient MonitorWaldo Health20111—
+4K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+4K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc.20101—
+4K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+4K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+4K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+4K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+4K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+4K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+4K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+4K063814BP-200 PlusSchiller AG20077—
+4K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+5K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K242290DormoTech NLabDormotech Medical, Ltd.20250—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K222597BabySat 3Owlet Babycare, Inc.20230—
+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—
+5K153600Consult Station TSH4D Sas20170—
+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—
+5K131021Pulse OximeterNonin Medical, Inc.20133—
+5K124062QDC-Pro, and Nox-RipNox Medical20133—
+5K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+5K122333Mobilecare MonitorAframe Digital, Inc.20120—
+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—
+5K113865PultolSharp Corporation20120—
+5K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+5K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+5K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+5K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K233827OxiWearOxiwear, Inc.20240—
+6K223721Masimo StorkMasimo Corporation20230—
+6K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+6K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+6K191403Pulse OximeterNonin Medical, Inc.20191—
+6K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—