FDA 510(k) Application Details - K231595

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K231595
Device Name	Pump, Breast, Powered
Applicant	Shenzhen Changkun Technology Co., Ltd. Room 501, Changkun Technology Building A, 12 Shijia Road Biling Community, Biling Subdistrict Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Wang Qingpeng 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	06/01/2023
Decision Date	10/26/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review