Nihon Kohden America, Inc. - FDA 510(k) Cleared Devices
Recent clearances: NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX, NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P, NIHON KOHDEN QP-160AK EEG TREND PROGRAM
166
Total
163
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nihon Kohden America, Inc. Cardiovascular ✕
94 devices
Cleared
Dec 24, 2008
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001...
Cardiovascular
48d
Cleared
Nov 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
Cardiovascular
64d
Cleared
Mar 28, 2008
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
Cardiovascular
101d
Cleared
Feb 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
Cardiovascular
18d
Cleared
Aug 30, 2007
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
Cardiovascular
21d
Cleared
Aug 17, 2007
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
Cardiovascular
21d
Cleared
Jun 29, 2007
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
Cardiovascular
74d
Cleared
May 24, 2006
CARDIOFAX CE, MODEL ECG-1500 A
Cardiovascular
252d
Cleared
Feb 03, 2005
TRANSMITTER, ZS-940PA SERIES
Cardiovascular
45d
Cleared
Jan 06, 2005
CARDIOFAX CE, MODEL PEA-1110K
Cardiovascular
86d
Cleared
Jun 01, 2004
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
Cardiovascular
105d
Cleared
Sep 16, 2003
BEDSIDE MONITOR, MODEL OPV-1500
Cardiovascular
11d
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