K253283
- 510(k) number
- K253283
- Device name
- Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-10-29
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253283.pdf
Official FDA record: K253283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.