Clearance Summary
Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) received FDA 510(k) clearance under submission number K182526, sponsored by Vcomin Technology Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2019-05-29.
- Submission: K182526
- Applicant / Sponsor: Vcomin Technology Limited
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2019-05-29
Classification & Regulation
This clearance is catalogued under FDA product code KNG and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.