| DeNovo ID | DEN170052 | 
| Device Name: | Natural Cycles | 
| Classification | Device, Fertility Diagnostic, Contraceptive, Software Application | 
| Applicant | Natural Cycles Nordic AB luntmakargatan 26  Stockholm,  SE 111-37 | 
| Contact | Raoul Scherwitzl | 
| Product Code | PYT | 
| CFR Regulation Number | 884.5370 [🔎] | 
| Decision | Granted (DENG) | 
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin | 
| Review Advisory Board | Obstetrics/Gynecology | 
| Classification Advisory | Obstetrics/Gynecology | 
| Type | Post-NSE | 
| Date Received | 2017-09-20 | 
| Decision Date | 2018-08-10 | 
| FDA Review | Decision Summary | 
| Reclassification Order: | Reclassification Order |