GWQ · Class II · 21 CFR 882.1400

FDA Product Code GWQ: Full-montage Standard Electroencephalograph

Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations

Leading manufacturers include Nihon Kohden America, Inc., Excel Tech. , Ltd. and Del Mar Avionics.

189
Total
189
Cleared
144d
Avg days
1977
Since
189 devices
25–48 of 189
Cleared Feb 16, 2018
NeuroEEG
K173460
Memory MD, Inc.
Neurology · 101d
Cleared Feb 01, 2018
Micromed BRAIN QUICK system
K171384
Micromed S.P.A.
Neurology · 266d
Cleared Dec 26, 2017
NEURONAUTE
K170138
Bioserenity
Neurology · 343d
Cleared Dec 13, 2017
eVox System
K171781
Evoke Neuroscience, Inc.
Neurology · 181d
Cleared Aug 25, 2017
Nihon Kohden Wireless Input Unit WEE-1200
K171124
Nihon Kohden Corporation
Neurology · 130d
Cleared Jun 05, 2017
ElectroTek
K170441
Mobilemedtek
Neurology · 111d
Cleared Jun 02, 2017
Enobio Wireless EEG
K162681
Neuroelectrics Barcelona S.L.U.
Neurology · 249d
Cleared Dec 14, 2016
XLTEK EMU40EX EEG Headbox
K163163
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology · 34d
Cleared Nov 04, 2016
Trex_HD
K162595
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology · 50d
Cleared Jan 26, 2016
Discovery 24
K150498
Brainmaster Technologies, Inc.
Neurology · 334d
Cleared Aug 13, 2015
Mitsar-EEG
K143233
Mitsar Co., Ltd.
Neurology · 276d
Cleared Apr 20, 2015
Natus Quantum
K143440
Natus Medical Incorporated
Neurology · 139d
Cleared Feb 03, 2015
BWMINI EEG, BWMINIHST, BWMINI PSG
K131335
Neurovirtual USA, Inc.
Neurology · 635d
Cleared Feb 14, 2014
TREZ_HD
K131266
Excel-Tech Ltd. (Xltek)
Neurology · 287d
Cleared Jan 29, 2014
CADWELL FLEX EEG/PSG
K133355
Cadwell Industries, Inc.
Neurology · 90d
Cleared Nov 27, 2013
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
K131383
Advanced Brain Monitoring, Inc.
Neurology · 197d
Cleared May 02, 2013
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
K122196
Blackrock Neuromed, LLC
Neurology · 282d
Cleared Nov 09, 2012
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
K120888
Nihon Kohden Corp.
Neurology · 231d
Cleared Jun 19, 2012
MICROEEG SYSTEM
K112817
Bio-Signal Group Corporation
Neurology · 265d
Cleared Mar 22, 2012
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117
Nihon Kohden America, Inc.
Neurology · 153d
Cleared Feb 17, 2012
GEODESIC EEG MOBILE 100 (GEM 100)
K112353
Electrical Geodesics, Inc.
Neurology · 185d
Cleared Oct 28, 2011
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
K112107
Neurovirtual USA, Inc.
Neurology · 98d
Cleared Aug 29, 2011
HARMONIE SYSTEM
K083577
Stellate Systems
Neurology · 999d
Cleared Jul 29, 2011
PE-210AK SWITCH BOX
K110376
Nihon Kohden Corp.
Neurology · 170d