K242846
- 510(k) number
- K242846
- Device name
- Doppler FHR Detector (BF-500D+, BF-560)
- Applicant
- Shenzhen Bestman Instrument Co., Ltd. CN
- Product code
- KNG — Monitor, Ultrasonic, Fetal
- Decision date
- 2025-06-26
- Date received
- 2024-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 5.6 MB · U.S. public domain
Also available from FDA: K242846.pdf
Official FDA record: K242846
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.