510(k) Report

Devices descending from K974496

337 later devices reach A-2000 Eeg Monitor with Bis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+1K042315Cerebral State Monitor - CSMDanmeter A/S20050—
+1K033543Narcotrend, Model Compact 4.0Mt Monitortechnik GmbH & Co. KG20040—
+1K030489BRM2 Brain MonitorBrainz Instruments, Ltd.200325—
+1K012466Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn2001305—
+1K983229Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp.199929—
+2K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+2K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+2K192572CNS EnvisionMoberg Research, Inc.20190—
+2K173366NicoletOneNatus Neurology Incorporated20183—
+2K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+2K072382Model I-2000 MonitorInfinite Biomedical Technologies200812—
+2K071449BRM3 Brain MonitorBrainz Instruments, Ltd.200715—
+2K033010BRM2 Brain MonitorBrainz Instruments, Ltd.200323—
+2K031694Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2003304—
+2K020335Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp.200218—
+3K251881HippoMind (v1.0)Hippoclinic20250—
+3K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+3K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+3K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+3K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc.20106—
+3K082886Zoom-100DCBrainscope Company, Inc.200911—
+3K081551Twin Neurotrac-IiiAstro-Med, Inc.20088—
+3K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2004303—
+3K031149Olympic CFM 6000Olympic Medical Corp.200317—
+4K213299Wireless EEG SystemPascall Systems, Inc.20222—
+4K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+4K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc.20155—
+4K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+4K131944IEEGJordan Neuroscience, Inc.20140—
+4K131789Cerebralogik- AeegMennen Medical, Ltd.20131—
+4K081140VisensiaObs Medical200822—
+4K053112BiosignOxford Biosignals Limited20068—
+4K052362Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc.200510—
+4K040183BISXAspect Medical Systems, Inc.2004274—
+5K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+5K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+5K192549Byteflies KitByteflies NV20201—
+5K152258T3 SoftwareEtiometry, Inc.201616—
+5K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+5K124038Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc.20132—
+5K110953Visensia, Visensia with AlertObs Medical201117—
+5K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+5K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc.200781
+5K071606Biosign Central StationObs Medical20070—
+5K062613Bis Eeg Monitor ViewAspect Medical Systems, Inc.20079—
+5K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+5K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH2005234—
+5K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005247—
+5K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+5K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH2005249—
+5K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005250—
+5K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004252—
+6K251550NX01 (NX01)Naox Technologies Sas20250—
+6K230693BIS™ Advance Monitoring SystemCovidien, LLC20241—
+6K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics, Ltd.20230—
+6K202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.20210—
+6K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+6K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+6K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+6K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+6K163065T3 SoftwareEtiometry, Inc.201715—
+6K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+6K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+6K131898A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd.20142—
+6K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+6K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+6K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+6K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+6K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+6K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+6K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+6K110922Patient MonitorEdan Instruments, Inc.201111
+6K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+6K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+6K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+6K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+6K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+6K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+6K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+6K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+6K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+6K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+6K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+6K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+6K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+6K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+6K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+6K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+6K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+6K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+6K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+6K052961The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors…Philips Medical Systems2005180—
+6K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH2004251—
+7K260907BIS™ Advance pEEG ModuleCovidien LP20260—
+7K230386SpassageQSpass, Inc.20231—
+7K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+7K190273T3 Platform softwareEtiometry, Inc.201914—
+7K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+7K183370PeraMobile and PeraWatchPerahealth, Inc.20190—