K021778 is an FDA 510(k) clearance for the PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 17, 2002, 48 days after receiving the submission on May 30, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K021778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2002 |
| Decision Date | July 17, 2002 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |