MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY

About This 510(k) Submission

K073051 is an FDA 510(k) clearance for the MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on May 30, 2008, 214 days after receiving the submission on October 29, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.