The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Ogs-2001a Pocketcare And Accessories.
| Device ID | K992455 |
| 510k Number | K992455 |
| Device Name: | NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES |
| Classification | Oximeter |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-23 |
| Decision Date | 2000-01-07 |
| Summary: | summary |