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Nihon Kohden Tomioka Corporation: FDA-registered device maker in Gunma Tokyo, Japan, 12 510(k) clearances

Name: Nihon Kohden Tomioka Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nihon Kohden Tomioka Corporation is registered with the FDA (registration 3007962724) in Gunma Tokyo, Japan. It lists 20 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 9, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007962724
Address: 486 Nanokaichi, Gunma Tokyo, Japan, 370-2343
Owner or operator: NIHON KOHDEN CORP. (8030227)
Roles: Manufacturer, Remanufacturer
First device listed: November 28, 2007
Registered through: 2026
Brand names listed: A/ABC300-11MED, A/AIRPHOTICKIT, A/DCIN1200, A/GCXCART, A/NIH8000, A/NIH9000, A/NWB-HL7CS, A/NWB-HL7NIS and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Manufacturer	accessdata.fda.gov
Device, Galvanic Skin Response Measurement	GZO	2	Manufacturer	accessdata.fda.gov
Device, Nerve Conduction Velocity Measurement	JXE	2	Manufacturer	accessdata.fda.gov
Electrode, Cortical	GYC	2	Manufacturer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 9, 2025	K251366	EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)	OLT	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
December 29, 2021	K213316	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	KOI	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
May 2, 2021	K201949	Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series	KOI	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
April 24, 2015	K142624	Neuromaster G1 MEE200	GWF	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
September 19, 2012	K120397	MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM	GWF	Substantially Equivalent	Nihon Kohden Corp.	accessdata.fda.gov
July 29, 2011	K110376	PE-210AK SWITCH BOX	GWQ	Substantially Equivalent	Nihon Kohden Corp.	accessdata.fda.gov
October 6, 2008	K071969	SEN-4100 ELECTRIC STIMULATOR	GWF	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
August 29, 2008	K080546	NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A	OLT	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
August 17, 2005	K051178	MEE-1000A NEUROMASTER	GWF	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
July 25, 2002	K020046	MULTIGAS UNIT, MODEL AG-920RA	CCK	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
June 28, 2001	K010590	NEUROPACK MICRO, MODEL MED-9100A SERIES	IKN	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
May 8, 2001	K011204	NEUROFAX, MODELS EEG-1100A, EEG-9100A	OLV	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.