FDA 510(k) Application Details - K121613

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K121613
Device Name	Pump, Infusion
Applicant	FRESENIUS KABI AG THREE CORPORATE DRIVE LAKE ZURICH, IL 60047 US Other 510(k) Applications for this Company
Contact	CHERYL ROSCHER Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2012
Decision Date	05/01/2013
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