FDA 510(k) Application Details - K243629

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K243629
Device Name	Pump, Breast, Powered
Applicant	ShenzhenáRootáInnovationáTechnologyáCo.,áLtd. #2-201, Floor 2, Hasee Computer Building, No.2 Beier Rd, Bantian Street, Longgang Shenzhen 518129 CN Other 510(k) Applications for this Company
Contact	Amy Dong Other 510(k) Applications for this Contact
Regulation Number	884.5160   More FDA Info for this Regulation Number
Classification Product Code	HGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2024
Decision Date	12/20/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review