Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007962724

FEI Number

3007962724

Entity Name

Nihon Kohden Tomioka Corporation

City/State/Country

Gunma Tokyo, JP

Establishment Address

486 Nanokaichi, Gunma Tokyo 370-2343, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NIHON KOHDEN CORP. (Owner Number: 8030227)

Owner / Operator Contact Address

1-31-4 NISHIOCHIAI, SHINJUKU-KU, TOKYO, JP-13 161-8560, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K010590

PMA Number

N/A

All Registered Proprietary Names

YG-220T cap-ONE Nasal Adapter, Pediatric, w/ Oxygen tube YG-221T YG-231T YG-230T cap-ONE Nasal Adapter, Pediatric cap-ONE Nasal Adapter, Adult, w/ Oxygen tube cap-ONE Nasal Adapter, Adult YG-213T YG-235T YG-214T YG-213T-A1 YG-225T YG-211T BM-412B JW-120B AG-920RA AG-920RA Mulitgas Unit NK-NEUROFAX-R TL-062S JE-213A A/TRACKTRANS JE-120A-24 NK-CENTRAL-150 QP-160R-10 TG-921T3 QI-123A A/RELAYBOX TL-274T JE-212A A/PHOTIC-3 A/SONYCART JE-208A JE-225AK NE-134A NK-CENTRAL-SW DI-120A EEG-1250A QP-110AK QI-124A AAA-17041 NK-REVSUITE-10 QI-122A A/POUCH-JE922 QD-120A NIHON KOHDEN EEG-1200A SERIES NEUROFAX EEG-1260A QI-120A NE-114A BC-112B JE-210A JE-120A-22 NK-REVSUITE-MU JE-915A KC-001A JE-921A QP-160AK JE-209A A/NIH8000 A/SONYCART-3 JE-214A YL-104A A/QP-160A-VS-10 KH-122A A/AIRPHOTICKIT KH-121A JE-922A KE-122A TL-271T EEG-1200A TL-201T NK-LS-901AJ NK-XPPSGRD-SFF A/DCIN1200 A/QP-160A-VS-25 JE-120A-23 JL-550T1 TL-052S EEG-1200A-T NK-REVSUITE-5 A/ABC300-11MED YL-103A A/NWB-HL7NIS NC-143E EEG-1200AA NE-113A JE-207A A/GCXCART A/NWB-HL7CS JE-226AK NE-311A A/POUCHTRIFOLD LS-703A TL-220T JE-227AK EEG-1200A-RAID QP-101BK MEE-1000A NEUROMASTER PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A TL-631T1 JS-210B JS-201B TL-260T JB-210B BM-121B NE-114A JL-550T1 TL-220T YG-135T TG-921T3 QI-120A MEE-2000A-DT QP-101BK DC-200B Neural Function Measuring System MEE-2000 YB-201B TL-631T3 Neuromaster G1 MEE-2000 TL-201T TL-062S NE-113A JS-202B BM-701B TL-052S YE-103J TL-051S JB-316B JB-232B JS-204B LS-102J YG-122T A/NWB-HL7CS TL-061S YG-125T NE-134A VD-403B MEE-2000A-LT DR-531B-14 JS-203B NMT Smart Pod Smart Cable NMT Pod, with EMG Support TOF Smart Pod TOF Pod TOF electrodes Life Scope BSM 3000 Series Bedside Monitors EMG electrodes JW-201P Main cable NMT Pod NMT electrodes AF-201P NMT module Disposable electrodes NM-345Y Disposable electrodes NMT Smart Cable TOF Pod DH-101P Holder Life Scope BSM 6000 Series Bedside Monitors MEB-2300A Neuropack Evoked Potential & EMG Measuring System QP-946BK BM-701B SC-900B DR-531B-14 KH-960A YZ-0172 RY-441B YE-103J DI-960B A/NIH9000 KD-019A BM-001B MEB-9400A-DT NE-134A QP-947BK LS-102J KH-001A JB-910B QP-948BK NE-430B RY-960B A/NWB-HL7CS JB-962B YZ-004A4 JB-964B MEB-9400A NE-132B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2023-05-18
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2008-10-08
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2007-11-28
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-11-28
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-11-28
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-11-28
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2007-11-28
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2007-11-28
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2008-10-07
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2008-10-07
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2008-10-07
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2007-11-28
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-02
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2011-08-02
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-04-29
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2021-06-18
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-09-20
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2012-09-20
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2012-09-20
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-09-20
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2012-09-20
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2012-09-20
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2007-11-28
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2007-11-28
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2007-11-28
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2007-11-28
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2007-11-28
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2007-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

Charlemagne Chua Business: NIHON KOHDEN AMERICA, LLC. Email: charlemagne_chua@nihonkohden.com Phone: (949) 3303964

Related Public Records

Same Entity

NIHON KOHDEN CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021736577	Nihon Vinyl Cord Corporation - Kodama Second Factory	Honjo-shi Saitama, JP
3030154814	Nihon Kohden America Fulfillment Center	Foothill Ranch, CA, US
2032233	Nihon Kohden Digital Health Solutions, LLC.	IRVINE, CA, US
3030516450	Nihon Vinyl Cord Corporation - Shimo-ongata Factory	Hachioji-shi Tokyo, JP
3007481893	Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center	Fukaya-Shi Saitama, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K040917	Philips Medizin Systeme Boeblingen GmbH	PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B	2004-04-29
K072469	Digiflo, Inc.	DIGIFLO CONCENTRATOR ANALYZER	2008-01-03
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007962724. Last updated year: 2026. Please use registration number 3007962724 when referencing this establishment in official correspondence.