K252669
- 510(k) number
- K252669
- Device name
- Fetal Doppler U8-25, U9-25
- Applicant
- Zhongshan Xiaolan Town Senlan Electronic Factory CN
- Product code
- KNG — Monitor, Ultrasonic, Fetal
- Decision date
- 2026-01-08
- Date received
- 2025-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252669.pdf
Official FDA record: K252669
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.