Medical Device Manufacturer · JP , Tokyo

Nihon Kohden Corporation - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2015

Recent clearances: GF-310R Multigas Unit (GF-310R), YP-710T Series NIBP Cuff, EEG-1260A Neurofax System (EEG-1260A)

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nihon Kohden Corporation Neurology ✕

6 devices

1-6 of 6

Cleared Oct 09, 2025

EEG-1260A Neurofax System (EEG-1260A)

Neurology · 161d

Cleared Feb 07, 2020

Elefix V Paste for EEG & EMG

Neurology · 198d

Cleared Mar 19, 2019

AE-120A EEG Head Set

Neurology · 90d

Cleared Aug 25, 2017

Nihon Kohden Wireless Input Unit WEE-1200

Neurology · 130d

Cleared May 19, 2017

Nihon Kohden QP-160AK EEG Trend Program

Neurology · 147d

Cleared Apr 24, 2015

Neuromaster G1 MEE200

Neurology · 220d