FDA 510(k) Application Details - K143612

Device Classification Name	Pump, Infusion, Pca   More FDA Info for this Device
510(K) Number	K143612
Device Name	Pump, Infusion, Pca
Applicant	Hospira, Inc 275 North Field Drive Lake Forest, IL 60045 US Other 510(k) Applications for this Company
Contact	Tom Gutierrez Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2014
Decision Date	04/08/2016
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