Nihon Kohden America, Inc. - FDA 510(k) Cleared Devices
166
Total
163
Cleared
0
Denied
166 devices
Cleared
Jul 09, 1997
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
Cardiovascular
99d
Cleared
Feb 19, 1997
NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
Anesthesiology
113d
Cleared
Nov 01, 1996
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
Cardiovascular
213d
Cleared
Nov 27, 1995
NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM
Cardiovascular
357d
Cleared
Nov 22, 1995
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
Cardiovascular
338d
Cleared
Nov 14, 1995
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
Cardiovascular
365d
Cleared
May 24, 1995
NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A
Cardiovascular
531d
Cleared
May 24, 1995
BSM-8800A BEDSIDE MONITOR
Cardiovascular
281d
Cleared
May 22, 1995
NIHON KOHDEN ELECTROENCEPHALOGRAPH
Neurology
242d
Cleared
May 10, 1995
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
Neurology
112d
Cleared
Aug 31, 1994
AG-839PA CO2 MODULE AND ACCESSORIES
Anesthesiology
14d
Cleared
Mar 01, 1994
CARDIOFAX Q ECG-8420A
Cardiovascular
650d
Cleared
Dec 18, 1992
BSM-8800A BEDSIDE MONITOR
Cardiovascular
340d
Cleared
Sep 03, 1992
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
Cardiovascular
202d
Cleared
May 28, 1992
BSM-2100A CONFIGURED PATIENT MONITOR
Cardiovascular
259d
Cleared
Apr 29, 1992
ZB-860PA MULTIPARAMETER TRANSMITTER
Cardiovascular
289d
Cleared
Mar 11, 1992
NEUROFAX EEG 5532
Neurology
120d
Cleared
Feb 26, 1992
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
Neurology
254d
Cleared
Dec 09, 1991
ORG-8200A UNIVERSAL SIGNAL HOUSING
Cardiovascular
171d
Cleared
Dec 04, 1991
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
Cardiovascular
47d
Cleared
Jun 28, 1991
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
Neurology
197d
Cleared
May 14, 1991
AP-860PA NIBP MODULE
Anesthesiology
90d
Cleared
Mar 19, 1991
EEG-5400 SERIES
Neurology
286d
Cleared
Feb 07, 1991
WEP-8430A TELEMETRY CENTRAL STATION
Cardiovascular
176d
Cleared
Dec 13, 1990
CARDIOFAX ECG-8830A
Cardiovascular
55d
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