510(k) Report

Devices descending from K930080

39 later devices reach E*Net Neuromonitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962447Equinox Digital Eeg SystemPhysiometrix, Inc.19968—
+1K962157Model 1310 Neurolink Neuromonitoring SystemPhysiometrix, Inc.19961—
+1K961609Model 1220, or E-Net (54-62 CM)Physiometrix, Inc.19960—
+1K960873Model 1210, Medium E-NetPhysiometrix, Inc.19960—
+1K960885Model 1240, Small E NetPhysiometrix, Inc.19960—
+1K960732Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500Physiometrix, Inc.199624—
+2K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+2K033010BRM2 Brain MonitorBrainz Instruments, Ltd.200323—
+2K970942Model 1320, Neurolink II Neuromonitoring SystemPhysiometrix, Inc.19970—
+3K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+3K192753NeuralScan SystemMedeia, Inc.20203—
+3K171781eVox SystemEvoke Neuroscience, Inc.20176—
+3K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+3K071449BRM3 Brain MonitorBrainz Instruments, Ltd.200715—
+4K253767UB ERP SystemUniversal Brain20260—
+4K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+4K221959Q21Neurofield, Inc.20230—
+4K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+4K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+4K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+4K192572CNS EnvisionMoberg Research, Inc.20190—
+4K173366NicoletOneNatus Neurology Incorporated20183—
+4K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+4K082886Zoom-100DCBrainscope Company, Inc.200911—
+4K081551Twin Neurotrac-IiiAstro-Med, Inc.20088—
+5K251881HippoMind (v1.0)Hippoclinic20250—
+5K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+5K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+5K131944IEEGJordan Neuroscience, Inc.20140—
+5K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+5K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc.20106—
+6K213299Wireless EEG SystemPascall Systems, Inc.20222—
+6K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+6K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc.20155—
+6K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+7K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+7K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+7K192549Byteflies KitByteflies NV20201—
+8K251550NX01 (NX01)Naox Technologies Sas20250—