510(k) Report

Devices descending from K031694

304 later devices reach Modification to Eeg Monitor with Bis, Model a-2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2004303—
+2K081140VisensiaObs Medical200822—
+2K053112BiosignOxford Biosignals Limited20068—
+2K052362Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc.200510—
+2K040183BISXAspect Medical Systems, Inc.2004274—
+3K152258T3 SoftwareEtiometry, Inc.201616—
+3K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+3K124038Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc.20132—
+3K110953Visensia, Visensia with AlertObs Medical201117—
+3K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+3K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc.200781
+3K071606Biosign Central StationObs Medical20070—
+3K062613Bis Eeg Monitor ViewAspect Medical Systems, Inc.20079—
+3K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+3K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH2005234—
+3K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005247—
+3K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+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—
+3K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004252—
+4K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+4K230693BIS™ Advance Monitoring SystemCovidien, LLC20241—
+4K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics, Ltd.20230—
+4K202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.20210—
+4K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+4K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+4K131898A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd.20142—
+4K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+4K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+4K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+4K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+4K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+4K110922Patient MonitorEdan Instruments, Inc.201111
+4K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+4K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+4K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+4K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+4K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+4K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+4K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+4K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+4K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+4K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+4K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+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—
+4K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+4K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+4K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+4K052961The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors…Philips Medical Systems2005180—
+4K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH2004251—
+5K260907BIS™ Advance pEEG ModuleCovidien LP20260—
+5K230386SpassageQSpass, Inc.20231—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K190273T3 Platform softwareEtiometry, Inc.201914—
+5K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+5K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+5K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K153156eCareManager 4.0.1Visicu, Inc.20163—
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+5K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+5K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+5K130401Alertwatch: orAlertwatch, LLC20148—
+5K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+5K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+5K120087ExspironRespiratory Motion, Inc.20128—
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+5K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+5K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+5K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+5K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+5K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+5K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+5K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+5K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+5K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883