Data / Medical devices / Japan / Nihon Kohden Tomioka Production Center

Nihon Kohden Tomioka Production Center: FDA-registered device maker in TOMIOKA-SHI Gunma, Japan, 44 510(k) clearances

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

Nihon Kohden Tomioka Production Center is registered with the FDA (registration 8030229) in TOMIOKA-SHI Gunma, Japan. It lists 27 device types. The FDA files 44 510(k) clearances under its listings, the newest dated July 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8030229
FEI number: 3002807739
Address: 1-1 Tajino, TOMIOKA-SHI Gunma, Japan, 370-2314
Owner or operator: NIHON KOHDEN CORP. (8030227)
Roles: Manufacturer
First device listed: October 31, 2007
Registered through: 2026
Brand names listed: A/326391 Cable, A/646225 Cable, A/ABC300-11MED, A/AIRPHOTICKIT, A/CE620NK, A/DCIN1200, A/EJ110-0010 Cable, A/FQW-50-2-100 and more

Devices it lists

Device	Product code	Class	Role	Source
Amplitude-Integrated Electroencephalograph	OMA	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer	accessdata.fda.gov
Automatic Event Detection Software For Full-Montage Electroencephalograph	OMB	2	Manufacturer	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Manufacturer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	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
Electrocardiograph	DPS	2	Manufacturer	accessdata.fda.gov
Electrode, Cortical	GYC	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	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	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	2	Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	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
July 21, 2022	K220976	Life Scope PT BSM-1700 Series Bedside Monitor	KOI	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
July 16, 2021	K203435	Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System	MHX	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
May 28, 2019	K190468	Nihon Kohden SVM-7200 Series Vital Signs Monitor	MWI	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
March 19, 2019	K183529	AE-120A EEG Head Set	OMC	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
October 11, 2017	K171765	Nihon Kohden CO2 Monitor	CCK	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
August 25, 2017	K171124	Nihon Kohden Wireless Input Unit WEE-1200	GWQ	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
May 19, 2017	K163644	Nihon Kohden QP-160AK EEG Trend Program	OMA	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
April 4, 2017	K163459	Nihon Kohden Vital Sign Telemeter	MHX	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
September 2, 2016	K153707	Nihon Kohden Vital Sign Telemeter	MHX	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
April 8, 2016	K152305	Nihon Kohden Afib Detection Program QP-039P	DSI	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
November 5, 2015	K151080	Nihon Kohden CSM 1901 Bedside Monitor	MHX	Substantially Equivalent	Nihon Kohden	accessdata.fda.gov
April 24, 2015	K142624	Neuromaster G1 MEE200	GWF	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
March 4, 2015	K130238	NIHON KOHDEN AE-918P NEURO UNIT	OMA	Substantially Equivalent	Nihon Kohden Corp.	accessdata.fda.gov
May 21, 2013	K122214	TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)	CCK	Substantially Equivalent	Nihon Kohden Corp.	accessdata.fda.gov
November 9, 2012	K120888	PSG-1100 SLEEP DIAGNOSTIC SYSTEM	GWQ	Substantially Equivalent	Nihon Kohden Corp.	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
March 22, 2012	K113117	NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX	GWQ	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
March 16, 2012	K120485	NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P	OMA	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
October 28, 2011	K110594	GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS	CCK	Substantially Equivalent	Nihon Kohden Corp.	accessdata.fda.gov
August 4, 2011	K110410	MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)	GYC	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
December 7, 2010	K102376	NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201	MHX	Substantially Equivalent	Nihon Kohden Corp.	accessdata.fda.gov
July 9, 2010	K092573	NIHON KOHDEN QP-160AK EEG TREND PROGRAM	OMA	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
March 2, 2009	K083456	NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P	CCK	Substantially Equivalent	Nihon Kohden America, Inc.	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
February 26, 2008	K080342	NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES	MHX	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
January 11, 2008	K073491	EEG-1100A SWITCH BOX	OLV	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
November 29, 2007	K072843	YG-125T AND YG-135T NASAL ADAPTER	CCK	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
August 30, 2007	K072217	ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M	DPS	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
June 29, 2007	K071058	MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A	DRG	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
December 27, 2006	K062115	CARBON DIOXIDE MONITOR, MODEL OLG-2800A	CCK	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
April 29, 2005	K050833	ELECTRODE JUNCTION BOX, MODEL JE-921A	OLV	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
February 3, 2005	K043517	TRANSMITTER, ZS-940PA SERIES	DRT	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
September 16, 2003	K032749	BEDSIDE MONITOR, MODEL OPV-1500	MWI	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
July 29, 2002	K022121	PSG INPUT BOX, MODEL JE-912AK	OLV	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
September 12, 2001	K011918	NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES	MHX	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
October 14, 1999	K992742	NEUROFAX, MODEL EEG-1100A	OLV	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
November 13, 1986	K862799	SKIN PURE	GYB	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 21, 2022. 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.