FDA 510(k) Application Details - K203148

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K203148
Device Name	Pump, Breast, Powered
Applicant	Ningbo Youhe Electrical Appliance Technology Co., Ltd. No.567, Xintang Road, Fuhai Town Cixi 315322 CN Other 510(k) Applications for this Company
Contact	Huang Yun Jun 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	10/22/2020
Decision Date	07/08/2021
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