K160582 is an FDA 510(k) clearance for the WiCap. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Athena Gtx (Johnson, US). The FDA issued a Cleared decision on September 2, 2016, 185 days after receiving the submission on March 1, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K160582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2016 |
| Decision Date | September 02, 2016 |
| Days to Decision | 185 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 |