DEN170052 is an FDA 510(k) submission 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 Not Cleared (DENG) decision on August 10, 2018.
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 | DEN170052 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 20, 2017 |
| Decision Date | August 10, 2018 |
| Days to Decision | 324 days |
| Submission Type | Post-NSE |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| 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). |