K032979 is an FDA 510(k) clearance for the PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Philips Medical Systems, Inc. (Boblingen, DE). The FDA issued a Cleared decision on February 20, 2004, 149 days after receiving the submission on September 24, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K032979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2003 |
| Decision Date | February 20, 2004 |
| Days to Decision | 149 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 |