K231969
- 510(k) number
- K231969
- Device name
- BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
- Applicant
- Dongguanshi Yiyingmei Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2024-08-30
- Date received
- 2023-07-03
- 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: K231969.pdf
Official FDA record: K231969
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.