510(k) K250561
- Device
- Natural Cycles
- Applicant
- Natural Cycles Nordic AB
- 510(k) number
- K250561
- Product code
- PYT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-21
- Date received
- 2025-02-25
- Regulation
- 884.5370
- Classification name
- Device, Fertility Diagnostic, Contraceptive, Software Application
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Megan Callanan
- Address
- Sankt Eriksgatan 63 B Stockholm SE 11234 11234
FDA Registration Numbers#
- 3014848805
Source Documents#
Other 510(k) Records For Product Code PYT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241006 | Natural Cycles | Natural Cycles Nordic AB | 2024-07-11 |
| K231274 | Natural Cycles | Natural Cycles Nordic AB | 2023-08-24 |
| K202897 | Natural Cycles | Natural Cycles Nordic AB | 2021-06-24 |
| K193330 | Clue Birth Control | Biowink GmbH | 2021-02-18 |
| DEN170052 | Natural Cycles | Natural Cycles Nordic AB | 2018-08-10 |