K874947 is an FDA 510(k) clearance for the MODEL 8800 CARDIORESPIRATORY OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 12, 1988, 72 days after receiving the submission on December 2, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K874947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1987 |
| Decision Date | February 12, 1988 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |