510(k) DEN170052
DEN170052 is an FDA 510(k) premarket notification submitted by Natural Cycles Nordic AB for the device "Natural Cycles". The FDA issued a decision of De Novo Granted on August 10, 2018. The device falls under product code PYT (Device, Fertility Diagnostic, Contraceptive, Software Application), a Class II device regulated under 21 CFR 884.5370. Natural Cycles Nordic AB has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 10, 2018
- Date Received
- September 20, 2017
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fertility Diagnostic, Contraceptive, Software Application
- Device Class
- Class II
- Regulation Number
- 884.5370
- Review Panel
- OB
- Submission Type
Designed to monitor and provide fertility information to prevent pregnancy (contraception).