MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM

About This 510(k) Submission

K061128 is an FDA 510(k) clearance for the MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on May 22, 2006, 28 days after receiving the submission on April 24, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.