The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Nihon Kohden Co2 Monitor.
| Device ID | K171765 |
| 510k Number | K171765 |
| Device Name: | Nihon Kohden CO2 Monitor |
| 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 | 2017-06-14 |
| Decision Date | 2017-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14931921904043 | K171765 | 000 |
| 04931921128664 | K171765 | 000 |
| 04931921128626 | K171765 | 000 |
| 04931921115596 | K171765 | 000 |
| 04931921115565 | K171765 | 000 |
| 04931921115558 | K171765 | 000 |
| 04931921107768 | K171765 | 000 |
| 00841983104152 | K171765 | 000 |