K100225 is an FDA 510(k) clearance for the PULSE OXIMETER MODEL P10. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Mediana Co., Ltd. (Echo, US). The FDA issued a Cleared decision on February 9, 2011, 379 days after receiving the submission on January 26, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K100225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2010 |
| Decision Date | February 09, 2011 |
| Days to Decision | 379 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 |