510(k) Report

Devices descending from K013930

22 later devices reach Neurosensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050702Neurosystems 1TM MonitorNeurosystems, LLC200517—
+1K050720Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models…Integra Neurosciences200511
+1K042728Camino Slim-Line Intracranial Monitoring SystemNovus Monitoring, Ltd.20041—
+2K172209Aura Icp Monitoring SystemBranchpoint Technologies, Inc.20180—
+2K101133Sensometrics SoftwareDpcom AS20100—
+2K071505Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring…Integra LifeSciences Corporation200701
+2K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation200615—
+3K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+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—
+5K251881HippoMind (v1.0)Hippoclinic20250—
+5K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+5K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+5K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+6K213299Wireless EEG SystemPascall Systems, Inc.20222—
+6K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+6K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+7K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+7K240593VEEGix EEG SystemNeuroServo, Inc.20240—