510(k) Report

Devices descending from K911529

27 later devices reach Bunny Electrode/Stealth Electrode Pre Wired Eeg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090180Tender-Trode Prewired Pediatric Ecg ElectrodeVermed, Inc.20090—
+1K033010BRM2 Brain MonitorBrainz Instruments, Ltd.200323—
+1K980619Sabratek Patient Home Management SystemSabratek Corp.19981—
+2K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+2K071449BRM3 Brain MonitorBrainz Instruments, Ltd.200715—
+2K993643Nexsystem Ambulatory Patient Monitor Model Nex 100Nexan Telemed, Ltd.19990—
+3K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+3K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+3K192572CNS EnvisionMoberg Research, Inc.20190—
+3K173366NicoletOneNatus Neurology Incorporated20183—
+3K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+3K082886Zoom-100DCBrainscope Company, Inc.200911—
+3K081551Twin Neurotrac-IiiAstro-Med, Inc.20088—
+4K251881HippoMind (v1.0)Hippoclinic20250—
+4K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+4K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+4K131944IEEGJordan Neuroscience, Inc.20140—
+4K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+4K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc.20106—
+5K213299Wireless EEG SystemPascall Systems, Inc.20222—
+5K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+5K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc.20155—
+5K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+6K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+6K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+6K192549Byteflies KitByteflies NV20201—
+7K251550NX01 (NX01)Naox Technologies Sas20250—