K033715 is an FDA 510(k) clearance for the PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Philips Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on February 13, 2004, 79 days after receiving the submission on November 26, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K033715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2003 |
| Decision Date | February 13, 2004 |
| Days to Decision | 79 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 |