The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Olg-100a Pocketcap Pocket Co2 Monitor With Accessories.
| Device ID | K964305 |
| 510k Number | K964305 |
| Device Name: | NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Gary Reasoner |
| Correspondent | Gary Reasoner NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1997-02-19 |
| Summary: | summary |