K063641 is an FDA 510(k) clearance for the PC-60, NON-INVASIVEPULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Creative Industry Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on July 13, 2007, 218 days after receiving the submission on December 7, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K063641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2006 |
| Decision Date | July 13, 2007 |
| Days to Decision | 218 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 |