510(k) K080297

MEDRAD INTEGO PET INFUSION SYSTEM by Medrad, Inc. — Product Code FRN

K080297 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD INTEGO PET INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 17, 2008. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Medrad, Inc. has at least 10 other 510(k) clearances on record.