510(k) K230102
K230102 is an FDA 510(k) premarket notification submitted by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. for the device "Smart double sides wearable breast pump, Electric bilateral breast pump". The FDA issued a decision of Substantially Equivalent on September 21, 2023. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Huizhou Lvb Maternal and Infant Supplies Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2023
- Date Received
- January 13, 2023
- Clearance Type
- Traditional
- 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