510(k) Report

Devices descending from K920429

441 later devices reach Modified Model M1403A Telemetry Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+4K102229Pulmotrack 2020 SystemKarmelsonix20110—
+4K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+4K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+4K081140VisensiaObs Medical200822—
+4K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+4K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+4K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+4K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+4K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+4K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+4K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+4K050128Vitalware VMSTelevital, Inc.20050—
+5K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+5K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+5K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…Philips Medizin Systeme Boeblingen GmbH20240—
+5K231964Novii+ Wireless Patch SystemDatex Ohmeda20231—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K220111RespiraSensePmd Solutions20221—
+5K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+5K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+5K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+5K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173248CardioskinBioserenity Sas20180—
+5K180017MX40 Release C.01Philips Medical Systems20181—
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K171244PhysiotraceNimbleheart, Inc.20170—
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K161431SimplECGNanowear, Inc.20165—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K153156eCareManager 4.0.1Visicu, Inc.20163—
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+5K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+5K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+5K152258T3 SoftwareEtiometry, Inc.201616—
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K150992Vios Monitoring SystemVios Medical, Inc.20157—
+5K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+5K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+5K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+5K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+5K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+5K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K110953Visensia, Visensia with AlertObs Medical201117—
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+5K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+5K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+5K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+5K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+6K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.20260—
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+6K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+6K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+6K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+6K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+6K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+6K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+6K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+6K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+6K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226