K053130 is an FDA 510(k) clearance for the ONYX II FINGER PULSE OXIMETER, MODEL 9550. 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 January 11, 2006, 64 days after receiving the submission on November 8, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K053130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2005 |
| Decision Date | January 11, 2006 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |