K063783 is an FDA 510(k) clearance for the PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A. 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 April 27, 2007, 127 days after receiving the submission on December 21, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K063783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2006 |
| Decision Date | April 27, 2007 |
| Days to Decision | 127 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 |