FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Natural Cycles
K Number: K250561
·
Decision Mar 21, 2025
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
5
Review Days
24
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Basic Information
- Device Name
- Natural Cycles
- K Number
- K250561
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.5370
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Natural Cycles Nordic AB
- Date Received
- February 25, 2025
- Decision Date
- March 21, 2025
- Product Code
- PYT
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PYT | Device, Fertility Diagnostic, Contraceptive, Software Application | FDA class 2 | Obstetrics/Gynecology |
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