K251977
- 510(k) number
- K251977
- Device name
- electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)
- Applicant
- Ningbo Youhe Electrical Appliance Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-10-22
- Date received
- 2025-06-27
- 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: K251977.pdf
Official FDA record: K251977
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.