510(k) K243629
Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430) by
Shenzhen Root Innovation Technology Co., , Ltd.
— Product Code HGX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2024
- Date Received
- November 25, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type