FDA 510(k) Application Details - K231785

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K231785
Device Name	Pump, Breast, Powered
Applicant	X6 Innovations 128 Rue La BoΘtie Paris 75008 FR Other 510(k) Applications for this Company
Contact	Artem Rodionov 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	06/20/2023
Decision Date	01/26/2024
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