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
49–72 of 189
Cleared Mar 03, 1994
CEEGRAPH, MODIFICATION
K933233
Bio-Logic Systems Corp.
Neurology · 316d
Cleared Mar 02, 1994
SPACELABS MEDICAL MODEL 90481 EEG MODULE
K932842
Spacelabs Medical, Inc.
Neurology · 264d
Cleared Mar 10, 1993
YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
K923894
Biosound, Inc.
Neurology · 218d
Cleared Feb 04, 1993
THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR
K923860
Biosound, Inc.
Neurology · 188d
Cleared Jan 26, 1993
THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH
K923950
Biosound, Inc.
Neurology · 174d
Cleared Mar 11, 1992
NEUROFAX EEG 5532
K915096
Nihon Kohden America, Inc.
Neurology · 120d
Cleared Aug 15, 1991
HORIZON 2000 EEG MONITORING OPTION
K910945
Mennen Medical, Inc.
Neurology · 162d
Cleared Apr 10, 1991
MENTOR EEG SYSTEM
K904763
Oxford Medilog, Inc.
Neurology · 170d
Cleared Mar 19, 1991
EEG-5400 SERIES
K902550
Nihon Kohden America, Inc.
Neurology · 286d
Cleared Nov 15, 1990
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004
Teca, Inc.
Neurology · 129d
Cleared Mar 08, 1990
SPACELABS MODEL 90480 EEG MODULE
K896942
Spacelabs, Inc.
Neurology · 85d
Cleared Feb 16, 1990
P460, DG32 ELECTROENCEPHALOGRAPH
K896666
Teca, Inc.
Neurology · 81d
Cleared Dec 22, 1989
CEEGRAPH
K895125
Bio-Logic Systems Corp.
Neurology · 129d
Cleared Sep 29, 1989
CADWELL FREEDOM EEG DEVICE
K894276
Cadwell Laboratories, Inc.
Neurology · 98d
Cleared Mar 23, 1989
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
K890881
Teca, Inc.
Neurology · 30d
Cleared Dec 29, 1988
AE-800PA EEG MODULE
K884537
Nihon Kohden America, Inc.
Neurology · 62d
Cleared Feb 01, 1988
KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265
K870815
Kontron Instruments, Inc.
Neurology · 335d
Cleared Jan 19, 1988
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K874796
Nihon Kohden America, Inc.
Neurology · 75d
Cleared Jul 21, 1987
AMBULATORY EEG PLAYBACK
K872183
Cadwell Laboratories, Inc.
Neurology · 43d
Cleared Jul 01, 1987
MODEL 5000 AMBULATORY MONITORING SYSTEM
K871500
Oxford Medilog, Inc.
Neurology · 76d
Cleared Oct 06, 1986
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
K863749
Teca, Inc.
Neurology · 12d
Cleared Aug 20, 1986
NEUROFAX 7310 SERIES (EEG)
K854663
Nihon Kohden America, Inc.
Neurology · 273d
Cleared Aug 11, 1986
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456
Oxford Medilog, Inc.
Neurology · 187d
Cleared Mar 27, 1986
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
K854268
Del Mar Avionics
Neurology · 155d