The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for C02 Monitor-oir-7101.
| Device ID | K841498 |
| 510k Number | K841498 |
| Device Name: | C02 MONITOR-OIR-7101 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NIHON KOHDEN AMERICA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-10 |
| Decision Date | 1984-05-14 |