FDA 510(k) Application Details - K201381

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K201381
Device Name	Pump, Breast, Powered
Applicant	Philips Consumer Lifestyle - Innovation Site Eindhoven High Tech Campus 37 Eindhoven 5656 AE NL Other 510(k) Applications for this Company
Contact	Aurore Millet 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	05/26/2020
Decision Date	10/01/2020
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