K241680
- 510(k) number
- K241680
- Device name
- Momcozy Wearable Breast Pump (BP311)
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2024-12-20
- Date received
- 2024-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241680
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.