510(k) K193330
K193330 is an FDA 510(k) premarket notification submitted by Biowink GmbH for the device "Clue Birth Control". The FDA issued a decision of Substantially Equivalent on February 18, 2021. The device falls under product code PYT (Device, Fertility Diagnostic, Contraceptive, Software Application), a Class II device regulated under 21 CFR 884.5370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2021
- Date Received
- December 2, 2019
- Clearance Type
- Abbreviated
- 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).