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

189
Total
189
Cleared
144d
Avg days
1977
Since
189 devices
25–48 of 189
Cleared Feb 01, 2018
Micromed BRAIN QUICK system
K171384
Micromed S.P.A.
Neurology · 266d
Cleared Mar 22, 2012
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117
Nihon Kohden America, Inc.
Neurology · 153d
Cleared Jul 19, 2011
ENTROPY EASYFIT SENSOR
K103129
Ge Healthcare
Neurology · 270d
Cleared Apr 21, 2006
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
K053386
Excel Tech. , Ltd.
Neurology · 137d
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 Oct 14, 1998
EXCEL AMBULATORY EEG
K982479
Excel Tech. , Ltd.
Neurology · 90d
Cleared Apr 21, 1998
EXCEL NEURO WORKS
K980214
Excel Tech. , Ltd.
Neurology · 90d
Cleared Mar 05, 1998
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM
K973883
Bio-Logic Systems Corp.
Neurology · 142d
Cleared Jan 25, 1996
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K954954
Bio-Logic Systems Corp.
Neurology · 87d
Cleared Sep 12, 1995
CADWELL EASY AMBULATORY EEG
K946094
Cadwell Laboratories, Inc.
Neurology · 272d
Cleared May 22, 1995
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678
Nihon Kohden America, Inc.
Neurology · 242d
Cleared Mar 22, 1994
CADWELL EASY WRITER AND EASY READER
K932407
Cadwell Laboratories, Inc.
Neurology · 308d