510(k) K242846
K242846 is an FDA 510(k) premarket notification submitted by Shenzhen Bestman Instrument Co., Ltd. for the device "Doppler FHR Detector (BF-500D+, BF-560)". The FDA issued a decision of Substantially Equivalent on June 26, 2025. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Shenzhen Bestman Instrument Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2025
- Date Received
- September 20, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Ultrasonic, Fetal
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type