FDA 510(k) Application Details - K052594

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K052594
Device Name	Pump, Infusion
Applicant	ICU MEDICAL INC 16787 BERNARDO CENTER DRIVE SUITE A-1 SAN DIEGO, CA 92128 US Other 510(k) Applications for this Company
Contact	SCOTT NELSON 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	09/21/2005
Decision Date	02/10/2006
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	Y
Expedited Review