510(k) Report

Devices descending from K983229

29 later devices reach Olympic Medical Lectromed Cerebral Function Monitor System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+1K071449BRM3 Brain MonitorBrainz Instruments, Ltd.200715—
+1K030489BRM2 Brain MonitorBrainz Instruments, Ltd.200325—
+1K020335Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp.200218—
+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—
+2K082886Zoom-100DCBrainscope Company, Inc.200911—
+2K081551Twin Neurotrac-IiiAstro-Med, Inc.20088—
+2K072382Model I-2000 MonitorInfinite Biomedical Technologies200812—
+2K033010BRM2 Brain MonitorBrainz Instruments, Ltd.200323—
+2K031149Olympic CFM 6000Olympic Medical Corp.200317—
+3K251881HippoMind (v1.0)Hippoclinic20250—
+3K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+3K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+3K131944IEEGJordan Neuroscience, Inc.20140—
+3K131789Cerebralogik- AeegMennen Medical, Ltd.20131—
+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—
+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—
+5K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+5K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+5K192549Byteflies KitByteflies NV20201—
+6K251550NX01 (NX01)Naox Technologies Sas20250—