K042306 is an FDA 510(k) clearance for the PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on October 15, 2004, 51 days after receiving the submission on August 25, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K042306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2004 |
| Decision Date | October 15, 2004 |
| Days to Decision | 51 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |