510(k) Report

Devices descending from K963644

340 later devices reach A-1000 Eeg Monitor and a-1050 Eeg Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+1K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc.200781
+1K991012Siemens Infinity Eeg PodSiemens Medical Solutions USA, Inc.19990—
+1K974496A-2000 Eeg Monitor with BisAspect Medical Systems, Inc.1998337—
+1K973596Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc.199830—
+2K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+2K230693BIS™ Advance Monitoring SystemCovidien, LLC20241—
+2K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics, Ltd.20230—
+2K202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.20210—
+2K131898A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd.20142—
+2K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+2K042315Cerebral State Monitor - CSMDanmeter A/S20050—
+2K033543Narcotrend, Model Compact 4.0Mt Monitortechnik GmbH & Co. KG20040—
+2K030489BRM2 Brain MonitorBrainz Instruments, Ltd.200325—
+2K012466Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn2001305—
+2K983229Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp.199929—
+3K260907BIS™ Advance pEEG ModuleCovidien LP20260—
+3K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+3K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+3K192572CNS EnvisionMoberg Research, Inc.20190—
+3K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+3K173366NicoletOneNatus Neurology Incorporated20183—
+3K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+3K072382Model I-2000 MonitorInfinite Biomedical Technologies200812—
+3K071449BRM3 Brain MonitorBrainz Instruments, Ltd.200715—
+3K033010BRM2 Brain MonitorBrainz Instruments, Ltd.200323—
+3K031694Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2003304—
+3K020335Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp.200218—
+4K251881HippoMind (v1.0)Hippoclinic20250—
+4K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+4K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+4K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+4K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+4K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc.20106—
+4K082886Zoom-100DCBrainscope Company, Inc.200911—
+4K081551Twin Neurotrac-IiiAstro-Med, Inc.20088—
+4K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2004303—
+4K031149Olympic CFM 6000Olympic Medical Corp.200317—
+5K213299Wireless EEG SystemPascall Systems, Inc.20222—
+5K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+5K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc.20155—
+5K131944IEEGJordan Neuroscience, Inc.20140—
+5K131789Cerebralogik- AeegMennen Medical, Ltd.20131—
+5K081140VisensiaObs Medical200822—
+5K053112BiosignOxford Biosignals Limited20068—
+5K052362Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc.200510—
+5K040183BISXAspect Medical Systems, Inc.2004274—
+6K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+6K192549Byteflies KitByteflies NV20201—
+6K152258T3 SoftwareEtiometry, Inc.201616—
+6K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+6K124038Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc.20132—
+6K110953Visensia, Visensia with AlertObs Medical201117—
+6K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+6K071606Biosign Central StationObs Medical20070—
+6K062613Bis Eeg Monitor ViewAspect Medical Systems, Inc.20079—
+6K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+6K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH2005234—
+6K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005247—
+6K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+6K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH2005249—
+6K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005250—
+6K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004252—
+7K251550NX01 (NX01)Naox Technologies Sas20250—
+7K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+7K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+7K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+7K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+7K163065T3 SoftwareEtiometry, Inc.201715—
+7K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+7K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+7K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+7K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+7K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+7K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+7K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+7K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+7K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+7K110922Patient MonitorEdan Instruments, Inc.201111
+7K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+7K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+7K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+7K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+7K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+7K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+7K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+7K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+7K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+7K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+7K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+7K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+7K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+7K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+7K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+7K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+7K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+7K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+7K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+7K052961The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors…Philips Medical Systems2005180—
+7K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH2004251—