FDA 510(k) Application Details - K222045

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K222045
Device Name	Pump, Breast, Powered
Applicant	Shenzhen TPH Technology Co.,Ltd. 5th floor, Building NO.29 Eastside Lianchuang 2nd technology park, Longgang District 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	07/11/2022
Decision Date	01/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review