510(k) Report

Devices descending from K011093

442 later devices reach Agilent Information Center Software for M3150,M3151,M3153 and M3154 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+4K101133Sensometrics SoftwareDpcom AS20100—
+4K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.)201013—
+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—
+4K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network20072—
+4K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+4K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+4K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+4K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+4K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+4K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+4K050128Vitalware VMSTelevital, Inc.20050—
+4K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004312—
+4K033513Easi Ecg AlgorithmPhilips Medical Systems2004220—
+4K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement ServerPhilips Medical Systems2003156—
+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—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K220111RespiraSensePmd Solutions20221—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+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
+5K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+5K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K180017MX40 Release C.01Philips Medical Systems20181—
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2017121
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+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
+5K141321Glucostabilizer Insulin Dosing CalculatorMedical Decision Network20140—
+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—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+5K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+5K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K113853G+ SystemGlytec, LLC201212—
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+5K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+5K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+5K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+5K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+5K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080—
+5K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+5K080173STAR 55Larsen & Toubro Limited20085—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+5K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+5K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+5K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638—
+5K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+5K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+5K041815LNCS Oximetry SensorsMasimo Corp.200486—
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.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—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+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—
+6K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226