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
49–72 of 189
Cleared Jul 19, 2011
ENTROPY EASYFIT SENSOR
K103129
Ge Healthcare
Neurology · 270d
Cleared Oct 31, 2008
NEUROLINK IP, MODEL PK1113
K081741
Excel-Tech Ltd. (Xltek)
Neurology · 134d
Cleared Sep 08, 2008
COMPUMEDICS NEUVO
K081151
Compumedics USA, Ltd.
Neurology · 138d
Cleared Jun 07, 2007
SACS EEG WORKSTATION A7
K071109
Sacs Medical AB
Neurology · 50d
Cleared Nov 06, 2006
NICOLETONE SYSTEM V32 AMPLIFIER
K061908
Viasys Neuro Care
Neurology · 124d
Cleared Apr 21, 2006
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
K053386
Excel Tech. , Ltd.
Neurology · 137d
Cleared Sep 12, 2005
COGNITRACE
K051825
Eemagine Medical Imaging Solutions GmbH
Neurology · 69d
Cleared Mar 28, 2005
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
K042626
Cyberkinetics, Inc.
Neurology · 182d
Cleared Jan 26, 2005
GEODESIC PHOTOGRAMMETRY SYSTEM
K043309
Electrical Geodesics, Incorporated
Neurology · 56d
Cleared Aug 27, 2004
XLTEK TREX MODEL#10309
K042150
Excel Tech. , Ltd.
Neurology · 18d
Cleared Mar 12, 2004
EMU128S, MODEL EX-NW-128S
K040360
Excel Tech. , Ltd.
Neurology · 28d
Cleared Aug 13, 2002
96 CHANNEL EEG HEADBOX MODEL EMU96
K021599
Excel Tech. , Ltd.
Neurology · 90d
Cleared Apr 09, 2001
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
K010086
Excel Tech. , Ltd.
Neurology · 88d
Cleared Mar 26, 2001
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
K010088
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K010089
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 16, 2001
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
K010084
Excel Tech. , Ltd.
Neurology · 64d
Cleared Feb 09, 2001
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150
Excel Tech. , Ltd.
Neurology · 23d
Cleared Feb 01, 2001
EEG WITH VIDEO, MODEL EX-NW
K010091
Excel Tech. , Ltd.
Neurology · 21d
Cleared Sep 14, 2000
BIO-LOGIC CEEGRAPH NETLINK
K002570
Bio-Logic Systems Corp.
Neurology · 27d
Cleared Aug 31, 2000
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
K000919
Excel Tech. , Ltd.
Neurology · 162d
Cleared Jun 30, 2000
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
K001103
Excel Tech. , Ltd.
Neurology · 86d
Cleared Apr 14, 2000
EEG WITH VIDEO, MODEL EX-NW
K000898
Excel Tech. , Ltd.
Neurology · 24d
Cleared Nov 03, 1999
BRAVO MULTI-MODALITY SYSTEM
K991054
Nicolet Biomedical, Inc.
Neurology · 218d
Cleared Oct 15, 1999
ACTITRAC
K992410
Individual Monitoring Systems, Inc.
Neurology · 87d