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
94 devices
76-94 of 94
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6105
K841502 · DRT
Cardiovascular · 140d
Cleared May 23, 1984
TEC-3500 DEFIBRILLATOR
K840258 · LDD
Cardiovascular · 121d
Cleared Apr 17, 1984
CARDIOFAX ECG 6543
K840274 · DRS
Cardiovascular · 85d
Cleared Oct 27, 1983
WLECTROCARDIOGRAPH ECG-7204
K831274 · DSI
Cardiovascular · 191d
Cleared Dec 22, 1982
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · DPS
Cardiovascular · 49d
Cleared Nov 24, 1982
COSMOS
K823220 · DPS
Cardiovascular · 23d
Cleared Nov 24, 1982
LIFESCOPE II/FOUR
K823249 · DRG
Cardiovascular · 23d
Cleared Apr 15, 1982
NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742 · DPW
Cardiovascular · 28d
Cleared Feb 12, 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · DPS
Cardiovascular · 32d
Cleared Jan 29, 1982
NIHON KOHDEN ELECTROCARDIOGRAPH
K813266 · DRS
Cardiovascular · 70d
Cleared Dec 29, 1981
NIHON KOHDEN HEART MONITORS OMP 7101-02
K813444 · DRT
Cardiovascular · 20d
Cleared Mar 11, 1981
STRESS TEST SYSTEM
K810357 · DPS
Cardiovascular · 29d
Cleared Oct 10, 1980
MLC-4200 CARDIAC OUTPUT COMPUTER
K802305 · DXG
Cardiovascular · 17d
Cleared Aug 07, 1980
ELECTROCARDIOGRAPH, MODEL ECG-5503
K801677 · DPS
Cardiovascular · 16d
Cleared Mar 05, 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3200
K800004 · DPS
Cardiovascular · 63d
Cleared Mar 05, 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3100
K800005 · DPS
Cardiovascular · 63d
Cleared Jan 09, 1980
CARDIAC OUTPUT COMPUTER, M-MLC-4100
K792678 · DXG
Cardiovascular · 14d
Cleared Nov 21, 1979
ELECTROCARDIOGRAPH, MODEL ECG-5151
K792229 · DPS
Cardiovascular · 16d
Cleared Sep 04, 1979
ELECTROCARDIOGRAPH MODEL ECG-5403
K791540 · DPS
Cardiovascular · 25d

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