K250207
- 510(k) number
- K250207
- Device name
- eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
- Applicant
- Anker Innovations Limited CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-08-11
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250207.pdf
Official FDA record: K250207
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.