Medical Device Manufacturer · JP , Tokyo

Nihon Kohden Corporation

18 submissions · 18 cleared · Since 2015
18
Total
18
Cleared
0
Denied

Nihon Kohden Corporation — FDA 510(k) Submissions

Nihon Kohden Corporation has submitted 18 FDA 510(k) premarket notifications since 2015, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Analyzer, Gas, Carbon-dioxide, Gaseous-phase, Stimulator, Nerve, Peripheral, Electric, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), Amplitude-integrated Electroencephalograph, Full-montage Standard Electroencephalograph . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
K251366 · OLT Non-normalizing... · Neurology
Oct 2025 161d
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
K243956 · CCK Analyzer, Gas,... · Anesthesiology
Jun 2025 169d
CNS-2101 Central Monitor
K223567 · MSX System, Network And... · Cardiovascular
Jul 2023 244d
Life Scope PT BSM-1700 Series Bedside Monitor
K220976 · KOI Stimulator, Nerve,... · Anesthesiology
Jul 2022 108d
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
K213316 · KOI Stimulator, Nerve,... · Anesthesiology
Dec 2021 86d
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
K203435 · MHX Monitor, Physiological,... · Cardiovascular
Jul 2021 235d
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
K201949 · KOI Stimulator, Nerve,... · Anesthesiology
May 2021 293d
Elefix V Paste for EEG & EMG
K191975 · GYB Media, Electroconductive · Neurology
Feb 2020 198d
Nihon Kohden SVM-7200 Series Vital Signs Monitor
K190468 · MWI Monitor, Physiological,... · Cardiovascular
May 2019 91d
AE-120A EEG Head Set
K183529 · OMC Reduced- Montage Standard... · Neurology
Mar 2019 90d
Nihon Kohden CO2 Monitor
K171765 · CCK Analyzer, Gas,... · Anesthesiology
Oct 2017 119d
Nihon Kohden Wireless Input Unit WEE-1200
K171124 · GWQ Full-montage Standard... · Neurology
Aug 2017 130d
Nihon Kohden QP-160AK EEG Trend Program
K163644 · OMA Amplitude-integrated... · Neurology
May 2017 147d
Nihon Kohden Vital Sign Telemeter
K163459 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2017 116d
TG-970P CO2 Sensor Kit
K161860 · CCK Analyzer, Gas,... · Anesthesiology
Feb 2017 233d
Nihon Kohden Vital Sign Telemeter
K153707 · MHX Monitor, Physiological,... · Cardiovascular
Sep 2016 254d
Nihon Kohden Afib Detection Program QP-039P
K152305 · DSI Detector And Alarm,... · Cardiovascular
Apr 2016 238d
Neuromaster G1 MEE200
K142624 · GWF Stimulator, Electrical,... · Neurology
Apr 2015 220d
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