FDA 510(k) Application Details - K162532

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K162532
Device Name	Accessories, Pump, Infusion
Applicant	WELLDOC, INC 10221 WINCOPIN CIRCLE SUITE 150 COLUMBIA, MD 21044 US Other 510(k) Applications for this Company
Contact	DANIELLE DORFMAN Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2016
Decision Date	01/12/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review