510(k) Report

Devices descending from K003621

527 later devices reach ST/AR ST and Arrhythmia Software, Model Release D.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH2005234—
+3K051366Piconibp Oem ModulePhilips Medizin Systeme Boeblingen GmbH200510—
+3K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005247—
+3K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH2005249—
+3K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005250—
+3K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH2004251—
+3K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Philips Medical Systems, Inc.20041554
+3K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004252—
+3K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Philips Medical Systems, Inc.200410—
+3K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004253—
+3K033715Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement ServerPhilips Medical Systems, Inc.20041863
+3K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement ServerPhilips Medical Systems2003156—
+3K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Philips Medizin Systeme Boblingen GmbH2003375—
+3K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003376—
+3K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc.2003404—
+3K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems2002406—
+4K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC20260—
+4K253463ILR ECG Analyzer (IM007)Implicity, Inc.20260—
+4K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…Philips Medizin Systeme Böblingen GmbH20260—
+4K250569Cardiologs Holter PlatformPhilips France Commercial20250—
+4K243252ZBPro DiagnosticZbeats, Inc.20251—
+4K243086Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable…Unimed Medical Supplies, Inc.20250—
+4K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+4K232161DeepRhythm PlatformMedicalgorithmics S.A.20240—
+4K223013AccurECG Analysis SystemAccurkardia, Inc.20231—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+4K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+4K201985KardiaAIAliveCor, Inc.20200—
+4K201040Bioflux Software IIBiotricity20200—
+4K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+4K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+4K183319Triangle SystemAliveCor, Inc.20193—
+4K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+4K172226MX40 Release B.07Philips Medical Systems201713—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K153156eCareManager 4.0.1Visicu, Inc.20163—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152552Patient MonitorEdan Instruments, Inc.201621
+4K152831Spot SkanSkanray Technologies Private Limited20160—
+4K151512Star 60Skanray Technologies Private Limited20160—
+4K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+4K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+4K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+4K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K130401Alertwatch: orAlertwatch, LLC20148—
+4K131032Philips Suresigns CentralPhilips Medical Systems20131—
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+4K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K120087ExspironRespiratory Motion, Inc.20128—
+4K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+4K112190Patient MonitorMediana Co., Ltd.20110—
+4K112652Suresigns VS2+ -Suresigns VsiPhilips Medical Systems201103
+4K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+4K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+4K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+4K110287Philips Ecg Leadwire SetPhilips Medical Systems201151
+4K101133Sensometrics SoftwareDpcom AS20100—
+4K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+4K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+4K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+4K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+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—
+4K063783Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Philips Medical Systems, Inc.200741—
+4K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+4K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+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—
+5K254255S-Patch CardioAIWellysis Corp.20260—
+5K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.20260—
+5K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.20250—
+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—
+5K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+5K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+5K242129VitalRhythmVitalconnect, Inc.20250—
+5K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+5K240901StethophoneSparrow Acoustics, Inc.20241—
+5K233755HeartKey® RhythmB-Secur Limited20240—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—