K910001 is an FDA 510(k) clearance for the MODEL 8604-FO PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Nonin Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 18, 1991, 197 days after receiving the submission on January 2, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K910001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1991 |
| Decision Date | July 18, 1991 |
| Days to Decision | 197 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 |