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
73–96 of 189
Cleared Jun 23, 1999
ACTIWATCH-SCORE
K991033
Mini-Mitter Co., Inc.
Neurology · 86d
Cleared Mar 23, 1999
ACTIWATCH
K983533
Mini-Mitter Co., Inc.
Neurology · 166d
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 Feb 26, 1998
NEUROAMP EEG AMPLIFIER
K974495
Neurocorp, Ltd.
Neurology · 90d
Cleared Nov 20, 1997
CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
K971329
Ctf Systems, Inc.
Neurology · 224d
Cleared Jul 23, 1997
DEEG-LITE
K972202
Grass-Telefactor Product Group
Neurology · 42d
Cleared Jun 25, 1997
SATELLITE
K971331
Nicolet Biomedical, Inc.
Neurology · 76d
Cleared Jun 02, 1997
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
K970942
Physiometrix, Inc.
Neurology · 80d
Cleared May 19, 1997
GALILEO HALLEY
K970703
Biosound Esaote, Inc.
Neurology · 82d
Cleared Jan 27, 1997
DG NERVUS
K964280
Medelec , Ltd.
Neurology · 91d
Cleared Jan 17, 1997
MEDILOG MR95
K961642
Oxford Instruments, Plc.
Neurology · 263d
Cleared Dec 12, 1996
EQUINOX DIGITAL EEG SYSTEM
K962447
Physiometrix, Inc.
Neurology · 171d
Cleared Nov 25, 1996
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM
K962157
Physiometrix, Inc.
Neurology · 174d
Cleared Jan 25, 1996
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K954954
Bio-Logic Systems Corp.
Neurology · 87d
Cleared Oct 12, 1995
MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
K953449
Physiometrix, Inc.
Neurology · 86d
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
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 Oct 19, 1993
E*NET NEUROMONITORING SYSTEM
K930080
Physiometrix, Inc.
Neurology · 285d
Cleared Mar 10, 1993
YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
K923894
Biosound, Inc.
Neurology · 218d