FDA 510(k) Application Details - K240218

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K240218
Device Name	Pump, Breast, Powered
Applicant	Fimilla (Shanghai) maternity & baby Articles Co., Ltd No. 65 Lane 3029 HuaXu Road HuaXin Town QingPu District Shanghai CN Other 510(k) Applications for this Company
Contact	Jason Liu 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	01/26/2024
Decision Date	10/17/2024
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