510(k) K213311
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2022
- Date Received
- October 4, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type