Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007481893

FEI Number

3007481893

Entity Name

Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center

City/State/Country

Fukaya-Shi Saitama, JP

Establishment Address

2909-63 Shirakusadai, Fukaya-Shi Saitama 369-1106, 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

N/A

PMA Number

N/A

All Registered Proprietary Names

ELEFIX ELECTRODE CREAM TG-980P TG-970P TG-980P1 TG-920P YG-135T YG-125T 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 TG-980P CO2 Sensor Kit with Smart Connector TG-980P1 CO2 Sensor Kit with Smart Connector TG-980P CO2 Sensor Kit TG-980P TG-980P1 CO2 Sensor Kit with Smart Cable TG-980P1 CO2 Sensor Kit TG-980P1 TG-980P CO2 Sensor Kit with Smart Cable YG-122T EMG ELECTRODES AND EXTENSION CORDS CNS-2101 Central Monitor DM-140P DZ-140P YS-122P7 YS-122P8 DH-140P WS-140P KG-210P P-Blade ITL-LL Airway Scope AWS-S200 P-Blade ITL-NL P-Blade ITL-PL P-Blade ITL-SL P-Blade ITL-TL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-03-13
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-02-11
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2023-05-18
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-08-20
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2007-11-28
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-09-20
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2023-09-20
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-09-20
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-09-20
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-12-18

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
3007962724	Nihon Kohden Tomioka Corporation	Gunma Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K152984	Bio Protech, Inc.	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes	2016-06-03
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09

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 3007481893. Last updated year: 2026. Please use registration number 3007481893 when referencing this establishment in official correspondence.