Medical Device Manufacturer · US , Foothill , CA

Nihon Kohden Corp.

9 submissions · 9 cleared · Since 2010
9
Total
9
Cleared
0
Denied

Nihon Kohden Corp. — FDA 510(k) Submissions

Nihon Kohden Corp. has submitted 9 FDA 510(k) premarket notifications since 2010, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Full-montage Standard Electroencephalograph, Analyzer, Gas, Carbon-dioxide, Gaseous-phase, Transmitters And Receivers, Physiological Signal, Radiofrequency, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), Electrode, Cortical . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
NIHON KOHDEN AE-918P NEURO UNIT
K130238 · OMA Amplitude-integrated... · Neurology
Mar 2015 762d
TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
K122214 · CCK Analyzer, Gas,... · Anesthesiology
May 2013 300d
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
K120888 · GWQ Full-montage Standard... · Neurology
Nov 2012 231d
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
K120397 · GWF Stimulator, Electrical,... · Neurology
Sep 2012 224d
GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
K110594 · CCK Analyzer, Gas,... · Anesthesiology
Oct 2011 240d
MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
K110410 · GYC Electrode, Cortical · Neurology
Aug 2011 171d
PE-210AK SWITCH BOX
K110376 · GWQ Full-montage Standard... · Neurology
Jul 2011 170d
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
K102106 · DRG Transmitters And... · Cardiovascular
Dec 2010 143d
NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
K102376 · MHX Monitor, Physiological,... · Cardiovascular
Dec 2010 109d
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