K202897 is an FDA 510(k) clearance for the Natural Cycles. This device is classified as a Device, Fertility Diagnostic, Contraceptive, Software Application (Class II - Special Controls, product code PYT).
Submitted by Natural Cycles Nordic AB (Stockholm, SE). The FDA issued a Cleared decision on June 24, 2021, 268 days after receiving the submission on September 29, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5370. Designed To Monitor And Provide Fertility Information To Prevent Pregnancy (contraception)..
| 510(k) Number | K202897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2020 |
| Decision Date | June 24, 2021 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PYT - Device, Fertility Diagnostic, Contraceptive, Software Application |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5370 |
| Definition | Designed To Monitor And Provide Fertility Information To Prevent Pregnancy (contraception). |