FDA 510(k) Application Details - K243508

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K243508
Device Name	Pump, Breast, Powered
Applicant	Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor, 29th Building, Lianchuang Technology Park, No.21 Bulan Road, Xialilang Community, Nanwan Street, Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Peter Chen 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	11/12/2024
Decision Date	04/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review