K052377 is an FDA 510(k) clearance for the PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.. 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 November 17, 2005, 79 days after receiving the submission on August 30, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K052377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2005 |
| Decision Date | November 17, 2005 |
| Days to Decision | 79 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 |