K250463
- 510(k) number
- K250463
- Device name
- Ameda GLO Wearable Breast Pump (Model W8S)
- Applicant
- Shenzhen TPH Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-03-20
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250463.pdf
Official FDA record: K250463
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.