510(k) K193330
- Device
- Clue Birth Control
- Applicant
- BioWink GmbH
- 510(k) number
- K193330
- Product code
- PYT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-18
- Date received
- 2019-12-02
- Regulation
- 884.5370
- Classification name
- Device, Fertility Diagnostic, Contraceptive, Software Application
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carrie Walter
- Address
- Adalbertstrasse 7-8 Berlin DE 10999 10999
FDA Registration Numbers#
- 3014848805
Source Documents#
Other 510(k) Records For Product Code PYT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250561 | Natural Cycles | Natural Cycles Nordic AB | 2025-03-21 |
| 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 |
| DEN170052 | Natural Cycles | Natural Cycles Nordic AB | 2018-08-10 |
Legacy Summary#
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FDA Review#
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