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
26-50 of 166
Cleared Mar 04, 2003
ANESTHESIA MONITOR
K030105 · MHX
Cardiovascular · 50d
Cleared Oct 24, 2002
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
K023475 · MHX
Cardiovascular · 8d
Cleared Jul 29, 2002
PSG INPUT BOX, MODEL JE-912AK
K022121 · OLV
Neurology · 28d
Cleared Jul 25, 2002
MULTIGAS UNIT, MODEL AG-920RA
K020046 · CCK
Anesthesiology · 199d
Cleared Sep 12, 2001
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL...
K011918 · MHX
Cardiovascular · 84d
Cleared Jun 28, 2001
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590 · IKN
Neurology · 121d
Cleared May 08, 2001
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K011204 · OLV
Neurology · 19d
Cleared Feb 08, 2001
ORG-9200A
K002068 · DSI
Cardiovascular · 216d
Cleared Nov 08, 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · DPS
Cardiovascular · 89d
Cleared Nov 07, 2000
CNS-9300 SERIES CENTRAL STATION
K001433 · MHX
Cardiovascular · 183d
Cleared Oct 24, 2000
LIFE SCOPE P, MODEL BSM-4100 SERIES
K001693 · MHX
Cardiovascular · 144d
Cleared Aug 31, 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · MHX
Cardiovascular · 197d
Cleared Apr 26, 2000
VITAPORT 3
K000338 · OLV
Neurology · 83d
Cleared Jan 07, 2000
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · DQA
Anesthesiology · 168d
Cleared Oct 14, 1999
NEUROFAX, MODEL EEG-1100A
K992742 · OLV
Neurology · 59d
Cleared Sep 01, 1999
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH...
K991899 · GWF
Neurology · 89d
Cleared Jun 09, 1999
NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
K990063 · CCK
Anesthesiology · 152d
Cleared Apr 16, 1999
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
K990031 · LOS
Cardiovascular · 101d
Cleared Apr 15, 1999
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
K984504 · LOS
Cardiovascular · 118d
Cleared Dec 01, 1998
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072 · OLV
Neurology · 90d
Cleared Jun 08, 1998
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · DQA
Anesthesiology · 206d
Cleared Jan 13, 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · DRT
Cardiovascular · 90d
Cleared Oct 21, 1997
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND...
K971436 · LDD
Cardiovascular · 186d
Cleared Aug 20, 1997
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A...
K972310 · DPS
Cardiovascular · 61d
Cleared Jul 15, 1997
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
K971355 · LDD
Cardiovascular · 95d

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