Data / Medical devices / Japan / Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center: FDA-registered device maker in Fukaya-Shi Saitama, Japan, 9 510(k) clearances
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center is registered with the FDA (registration 3007481893) in Fukaya-Shi Saitama, Japan. It lists 9 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 10, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007481893
- Address
- 2909-63 Shirakusadai, Fukaya-Shi Saitama, Japan, 369-1106
- Owner or operator
- NIHON KOHDEN CORP. (8030227)
- Roles
- Manufacturer
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- Airway Scope AWS-S200, CNS-2101 Central Monitor, DH-140P, DM-140P, DZ-140P, ELEFIX ELECTRODE CREAM, EMG ELECTRODES AND EXTENSION CORDS, JG-900P and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Needle, Diagnostic Electromyograph | IKT | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 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 |
| System, Network And Communication, Physiological Monitors | MSX | 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 |
|---|---|---|---|---|---|---|
| June 10, 2025 | K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | CCK | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| July 31, 2023 | K223567 | CNS-2101 Central Monitor | MSX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| February 7, 2020 | K191975 | Elefix V Paste for EEG & EMG | GYB | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| February 24, 2017 | K161860 | TG-970P CO2 Sensor Kit | CCK | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| November 29, 2007 | K072843 | YG-125T AND YG-135T NASAL ADAPTER | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 15, 2004 | K040875 | CAP-ONE, MODEL TG-920P | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| June 9, 1999 | K990063 | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| March 13, 1987 | K870795 | EMG ELECTRODES AND EXTENSION CORDS | IKT | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| July 1, 1986 | K860210 | ELEFIX ELECTRODE CREAM | GYB | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Electroconductive
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Amplifier And Signal Conditioner, Transducer Signal
- All makers of System, Network And Communication, Physiological Monitors
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Updated June 10, 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.