Medical Device Manufacturer · US , Foothill Ranch , CA

Nihon Kohden America, Inc.

166 submissions · 163 cleared · Since 1979
166
Total
163
Cleared
0
Denied

Nihon Kohden America, Inc. — FDA 510(k) Submissions

Nihon Kohden America, Inc. has submitted 166 FDA 510(k) premarket notifications since 1979, of which 163 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrocardiograph, Detector And Alarm, Arrhythmia, Full-montage Standard Electroencephalograph, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) . Use the specialty filter in the sidebar to narrow results.

166 devices
1–25 of 166
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117 · GWQ Full-montage Standard... · Neurology
Mar 2012 153d
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
K120485 · OMA Amplitude-integrated... · Neurology
Mar 2012 28d
NIHON KOHDEN QP-160AK EEG TREND PROGRAM
K092573 · OMA Amplitude-integrated... · Neurology
Jul 2010 323d
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
K083456 · CCK Analyzer, Gas,... · Anesthesiology
Mar 2009 101d
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
K083271 · MHX Monitor, Physiological,... · Cardiovascular
Dec 2008 48d
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
K082785 · MHX Monitor, Physiological,... · Cardiovascular
Nov 2008 64d
SEN-4100 ELECTRIC STIMULATOR
K071969 · GWF Stimulator, Electrical,... · Neurology
Oct 2008 447d
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
K080546 · OLT Non-normalizing... · Neurology
Aug 2008 183d
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
K073550 · MHX Monitor, Physiological,... · Cardiovascular
Mar 2008 101d
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
K080342 · MHX Monitor, Physiological,... · Cardiovascular
Feb 2008 18d
EEG-1100A SWITCH BOX
K073491 · OLV Standard Polysomnograph... · Neurology
Jan 2008 30d
YG-125T AND YG-135T NASAL ADAPTER
K072843 · CCK Analyzer, Gas,... · Anesthesiology
Nov 2007 56d
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · DPS Electrocardiograph · Cardiovascular
Aug 2007 21d
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
K072060 · DPS Electrocardiograph · Cardiovascular
Aug 2007 21d
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
K071058 · DRG Transmitters And... · Cardiovascular
Jun 2007 74d
CARBON DIOXIDE MONITOR, MODEL OLG-2800A
K062115 · CCK Analyzer, Gas,... · Anesthesiology
Dec 2006 156d
CARDIOFAX CE, MODEL ECG-1500 A
K052511 · DPS Electrocardiograph · Cardiovascular
May 2006 252d
MEE-1000A NEUROMASTER
K051178 · GWF Stimulator, Electrical,... · Neurology
Aug 2005 100d
ELECTRODE JUNCTION BOX, MODEL JE-921A
K050833 · OLV Standard Polysomnograph... · Neurology
Apr 2005 28d
TRANSMITTER, ZS-940PA SERIES
K043517 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Feb 2005 45d
CARDIOFAX CE, MODEL PEA-1110K
K042827 · DPS Electrocardiograph · Cardiovascular
Jan 2005 86d
CAP-ONE, MODEL TG-920P
K040875 · CCK Analyzer, Gas,... · Anesthesiology
Oct 2004 196d
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
K040395 · MHX Monitor, Physiological,... · Cardiovascular
Jun 2004 105d
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
K033475 · OLV Standard Polysomnograph... · Neurology
Jan 2004 65d
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · MWI Monitor, Physiological,... · Cardiovascular
Sep 2003 11d

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