K120502 is an FDA 510(k) clearance for the PC-60NW FINGERTIP OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Creative Industry Co., Ltd. (Echo, US). The FDA issued a Cleared decision on December 7, 2012, 290 days after receiving the submission on February 21, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K120502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2012 |
| Decision Date | December 07, 2012 |
| Days to Decision | 290 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 |