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
+1K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+1K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+1K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc.200770—
+1K070260Star ST and Arrhythmia Software, Release H.0Philips Medical Systems20077—
+1K052707M3046B Compact Portable Patient MonitorsPhilips Medical Systems2005211
+1K043380Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc.200571—
+1K021251ST/AR ST and Arrhythmia Software, Release E.I.Philips Medical Systems2002262—
+1K014261ST/AR ST and Arrhythmia Software, Model Release E.0Philips Medical Systems, Inc.2002263—
+1K013717Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp.200272—
+1K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc.2001431—
+2K200036AI-ECG TrackerShenzhen Carewell Electronics Co., Ltd.20200—
+2K182093ZOLL ECG Analysis SoftwareZoll Manufacturing Corporation20190—
+2K180234physiQ Heart Rhythm ModulePhysiq, Inc.20187—
+2K170568CardioLogs ECG Analysis PlatformCardiologs Technologies201726—
+2K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+2K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+2K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+2K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+2K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+2K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+2K142693ZywieAI Software LibraryZywie, Inc.20150—
+2K122632Guava IICardiocomm Solutions, Inc.20142—
+2K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+2K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+2K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+2K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+2K103652Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8Philips Medical Systesms20116—
+2K101067Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068Philips Medical Systems201071
+2K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+2K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc.200932—
+2K090483Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series…Philips Medical Systems2009145
+2K082280Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital…Philips Medical Systems North America Co.200811—
+2K080495Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems2008181
+2K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638—
+2K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc.2004260—
+2K030973Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems2003198—
+2K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002407—
+2K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002421—
+2K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems2002416—
+3K251218SafeBeat Rx AppSafeBeat Rx, Inc.20260—
+3K212112Cardiologs Holter PlatformCardiologs Technologies20217—
+3K210543IM007Implicity, Inc.20211—
+3K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+3K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+3K181823KardiaAIAliveCor, Inc.20196—
+3K182344RhythmAnalyticsBiofourmis Singapore Pte., Ltd.20197—
+3K162571Bioflux SoftwareBiotricity, Inc.20161—
+3K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K142352CardiacLinxRoss Medical Technology, Inc.20150—
+3K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc.201431—
+3K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+3K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+3K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+3K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+3K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+3K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+3K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+3K120132Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems20126—
+3K113653Patient MonitorEdan Instruments, Inc.201212
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+3K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+3K110803Suresigns Vsi Vital Signs MonitorPhilips Medical Systems20111—
+3K111114Suresigns VS2 Vital Signs MonitorPhilips Medical Systems20111—
+3K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+3K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+3K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+3K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+3K102430Tyco Electronics Electrocardiograph (Ecg) Leadwire SetTyco Electronics Corporation20106—
+3K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+3K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+3K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+3K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+3K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+3K090438Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15…Envitec-Wismar GmbH20090—
+3K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—
+3K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+3K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+3K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+3K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+3K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+3K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+3K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+3K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+3K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+3K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+3K062605Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems200646—
+3K062455Philips Adult Reusable SP02 Sensor, Model M1191B, M1191BL, M1191BNLPhilips Medical Systems20060—
+3K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+3K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+3K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+3K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+3K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+3K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+3K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+3K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+3K052961The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors…Philips Medical Systems2005180—