K252630
- 510(k) number
- K252630
- Device name
- Electric Breast Pump (HL-3060, F5113)
- Applicant
- Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-10-27
- Date received
- 2025-08-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252630.pdf
Official FDA record: K252630
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.