K250070
- 510(k) number
- K250070
- Device name
- Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
- Applicant
- Shenzhen Changkun Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-06-26
- Date received
- 2025-01-10
- 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: K250070.pdf
Official FDA record: K250070
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.