K250561
- 510(k) number
- K250561
- Device name
- Natural Cycles
- Applicant
- Natural Cycles Nordic AB SE
- Product code
- PYT — Device, Fertility Diagnostic, Contraceptive, Softwar
- Decision date
- 2025-03-21
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250561.pdf
Official FDA record: K250561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.