The following data is part of a premarket notification filed by Ava Ag with the FDA for Ava Fertility Tracker.
| Device ID | K200163 |
| 510k Number | K200163 |
| Device Name: | Ava Fertility Tracker |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | Ava AG Gustrasse 73 Zurich, CH 8055 |
| Contact | Blathnaid Feldman |
| Correspondent | Blathnaid Feldman Ava AG Gustrasse 73 Zurich, CH 8055 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-22 |
| Decision Date | 2021-01-19 |
| Summary: | summary |