K062268 is an FDA 510(k) clearance for the MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Philips Medical Systems North America Co. (Andover, US). The FDA issued a Cleared decision on October 18, 2006, 72 days after receiving the submission on August 7, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K062268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2006 |
| Decision Date | October 18, 2006 |
| Days to Decision | 72 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |