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
166 devices
101-125 of 166
Cleared Mar 10, 1987
CARDIOFAX-V ECG-8240A
K865030 · DSI
Cardiovascular · 77d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-834OA
K865032 · DSI
Cardiovascular · 77d
Cleared Feb 19, 1987
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · DXG
Cardiovascular · 478d
Cleared Feb 19, 1987
ELECTROCARDIOGRAPH
K865031 · DPS
Cardiovascular · 58d
Cleared Feb 03, 1987
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · BZQ
Anesthesiology · 218d
Cleared Dec 05, 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · DRT
Cardiovascular · 158d
Cleared Nov 13, 1986
SKIN PURE
K862799 · GYB
Neurology · 114d
Cleared Oct 31, 1986
CARDIOLIFE TEC 7100
K863404 · LDD
Cardiovascular · 58d
Cleared Oct 31, 1986
CARDIOLIFE TEC 7200
K863405 · LDD
Cardiovascular · 58d
Cleared Sep 17, 1986
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
K863116 · DPS
Cardiovascular · 34d
Cleared Sep 05, 1986
OMF-7101 FETAL MONITOR
K860237 · HGM
Obstetrics & Gynecology · 225d
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 26, 1986
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
K860239 · DRG
Cardiovascular · 154d
Cleared Jun 05, 1986
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
K854665 · OLV
Neurology · 197d
Cleared Apr 28, 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · DXN
Cardiovascular · 181d
Cleared Apr 17, 1986
CARDIOFAX ECG-6353
K860212 · DPS
Cardiovascular · 85d
Cleared Apr 09, 1986
LONG TERM RECORDER RAG 1200
K854866 · DSF
Cardiovascular · 152d
Cleared Feb 28, 1986
WEP 7604 TELEMETRY MONITOR
K854369 · DXH
Cardiovascular · 122d
Cleared Feb 28, 1986
VM 781 SLAVE SCOPE
K854372 · DXJ
Cardiovascular · 122d
Cleared Jul 30, 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270 · DSI
Cardiovascular · 63d
Cleared Jun 13, 1985
NEUROPACK 8, MEE-4108
K851300 · GWF
Neurology · 73d
Cleared Apr 18, 1985
DISPLAY MONITOR (VD-711RA-VD-712RA)
K850343 · DXJ
Cardiovascular · 80d

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