Medical Device Manufacturer · US , Foothill Ranch , CA

Nihon Kohden America, Inc. - FDA 510(k) Cleared Devices

166 submissions · 163 cleared · Since 1979
166
Total
163
Cleared
0
Denied
48 devices
26-48 of 48
Cleared Jan 19, 1988
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K874796 · GWQ
Neurology · 75d
Cleared Sep 30, 1987
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · GWL
Neurology · 216d
Cleared Mar 13, 1987
EMG ELECTRODES AND EXTENSION CORDS
K870795 · IKT
Neurology · 15d
Cleared Nov 13, 1986
SKIN PURE
K862799 · GYB
Neurology · 114d
Cleared Aug 20, 1986
OEE_7102 EEG/TREND MONITOR
K854662 · GWS
Neurology · 273d
Cleared Aug 20, 1986
NEUROFAX 7310 SERIES (EEG)
K854663 · GWQ
Neurology · 273d
Cleared Aug 14, 1986
MEB-5200
K854664 · IKT
Neurology · 267d
Cleared Jul 01, 1986
ELEFIX ELECTRODE CREAM
K860210 · GYB
Neurology · 160d
Cleared Jun 05, 1986
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
K854665 · OLV
Neurology · 197d
Cleared Jun 13, 1985
NEUROPACK 8, MEE-4108
K851300 · GWF
Neurology · 73d
Cleared Nov 09, 1984
SLS 3500 LED VISUAL STIMULATOR
K842381 · GWE
Neurology · 144d
Cleared Sep 25, 1984
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K842714 · GWQ
Neurology · 75d
Cleared Jun 07, 1984
NEUROPACK 8 MEE 4108
K841497 · GWK
Neurology · 58d
Cleared Jun 07, 1984
NEUROPACK II 5100
K841612 · GWL
Neurology · 58d
Cleared May 27, 1983
EEG 42/2P ELECTRO ENCEPHALOGRAPH
K831324 · GWQ
Neurology · 32d
Cleared Jan 14, 1983
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · IKN
Neurology · 43d
Cleared Dec 07, 1982
ELECTROENCEPHALOGRAPH
K823140 · GWQ
Neurology · 36d
Cleared Feb 04, 1982
ELECTROENCEPHALOGRAPHS EEG-5208,5210
K820066 · GWQ
Neurology · 24d
Cleared Dec 16, 1980
MODEL EEG 4221
K802887 · GWQ
Neurology · 29d
Cleared Sep 17, 1979
STIMULATOR MODEL SSS-1101
K791149 · GWE
Neurology · 94d
Cleared Sep 12, 1979
ELECTROENCEPHALOGRAPHS MODELS 7209,7213
K791150 · GWQ
Neurology · 89d
Cleared Sep 12, 1979
MODEL EEG-4214 ELECTROENCEPHALOGRAPH
K791233 · GWQ
Neurology · 75d
Cleared Sep 12, 1979
MODEL EEG-4217 ELECTROENCEPHALOGRAPH
K791234 · GWQ
Neurology · 75d
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