510(k) K230102

Smart double sides wearable breast pump, Electric bilateral breast pump by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. — Product Code HGX

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