510(k) Report

Devices descending from K020335

18 later devices reach Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031149Olympic CFM 6000Olympic Medical Corp.200317—
+2K131789Cerebralogik- AeegMennen Medical, Ltd.20131—
+2K081551Twin Neurotrac-IiiAstro-Med, Inc.20088—
+2K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+3K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+3K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+3K192572CNS EnvisionMoberg Research, Inc.20190—
+3K173366NicoletOneNatus Neurology Incorporated20183—
+3K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+3K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+4K251881HippoMind (v1.0)Hippoclinic20250—
+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—
+5K213299Wireless EEG SystemPascall Systems, Inc.20222—
+5K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+6K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+6K240593VEEGix EEG SystemNeuroServo, Inc.20240—