The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Tg-970p Co2 Sensor Kit.
| Device ID | K161860 |
| 510k Number | K161860 |
| Device Name: | TG-970P CO2 Sensor Kit |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NIHON KOHDEN CORPORATION 1-31-4 NISHIOCHIAI, SHINJUKU-KU Tokyo, JP 161-8560 |
| Contact | Thomas Bento |
| Correspondent | Thomas Bento NIHON KOHDEN AMERICA, INC. 15353 BARRANCA PARKWAY Irvine, CA 92618 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-06 |
| Decision Date | 2017-02-24 |
| Summary: | summary |