510(k) Report

Devices descending from K010728

16 later devices reach Harmone-Schwarzer Eeg System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083577Harmonie SystemStellate Systems201101
+1K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+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—
+3K251881HippoMind (v1.0)Hippoclinic20250—
+3K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+3K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+3K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+4K213299Wireless EEG SystemPascall Systems, Inc.20222—
+4K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+4K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+5K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+5K240593VEEGix EEG SystemNeuroServo, Inc.20240—