Nihon Kohden America, Inc. - FDA 510(k) Cleared Devices
166
Total
163
Cleared
0
Denied
94 devices
Cleared
Jul 15, 1997
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
Cardiovascular
95d
Cleared
Jul 09, 1997
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
Cardiovascular
99d
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
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
Dec 09, 1991
ORG-8200A UNIVERSAL SIGNAL HOUSING
Cardiovascular
171d
Cleared
Dec 04, 1991
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
Cardiovascular
47d
Cleared
Feb 07, 1991
WEP-8430A TELEMETRY CENTRAL STATION
Cardiovascular
176d
Cleared
Dec 13, 1990
CARDIOFAX ECG-8830A
Cardiovascular
55d
Cleared
Apr 19, 1990
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
Cardiovascular
44d
Cleared
Jan 31, 1990
NKA MODELS AB-601G AND AB-621G
Cardiovascular
21d
Cleared
Jan 19, 1990
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
Cardiovascular
179d
Cleared
Dec 20, 1989
NKA MODEL SEC-3102 CARDIAC STIMULATOR
Cardiovascular
155d
Cleared
Oct 02, 1989
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
Cardiovascular
70d
Cleared
Oct 02, 1989
AP-851PA NIBP MODULE
Cardiovascular
70d
Cleared
Nov 09, 1988
OEC-7102 ECG/NIBP MONITOR
Cardiovascular
162d
Cleared
Nov 09, 1988
MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A
Cardiovascular
50d
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