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 |