K161871 is an FDA 510(k) clearance for the EVA (Enhanced Visual Assessment) System. This device is classified as a Colposcope (and Colpomicroscope) (Class II — Special Controls, product code HEX).
Submitted by Mobileodt , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on December 19, 2016, 165 days after receiving the submission on July 7, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K161871 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 07, 2016 |
| Decision Date | December 19, 2016 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEX — Colposcope (and Colpomicroscope) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1630 |