510(k) K250561
K250561 is an FDA 510(k) premarket notification submitted by Natural Cycles Nordic AB for the device "Natural Cycles". The FDA issued a decision of Substantially Equivalent on March 21, 2025. 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
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2025
- Date Received
- February 25, 2025
- Clearance Type
- Special
- 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).