K200163 is an FDA 510(k) clearance for the Ava Fertility Tracker. This device is classified as a Device, Fertility Diagnostic, Proceptive.
Submitted by Ava AG (Zurich, CH). The FDA issued a Cleared decision on January 19, 2021, 363 days after receiving the submission on January 22, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel.
| 510(k) Number | K200163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2020 |
| Decision Date | January 19, 2021 |
| Days to Decision | 363 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LHD - Device, Fertility Diagnostic, Proceptive |
| Device Class | - |