Clearance Summary
Doppler FHR Detector (BF-500D+, BF-560) received FDA 510(k) clearance under submission number K242846, sponsored by Shenzhen Bestman Instrument Co., Ltd.. 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 2025-06-26.
- Submission: K242846
- Applicant / Sponsor: Shenzhen Bestman Instrument Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2025-06-26
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.