K083010 is an FDA 510(k) clearance for the SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Nederland, US). The FDA issued a Cleared decision on June 10, 2009, 244 days after receiving the submission on October 9, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K083010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2008 |
| Decision Date | June 10, 2009 |
| Days to Decision | 244 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 |