510(k) K100798

MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C by Medrad, Inc. — Product Code FRN

K100798 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C". The FDA issued a decision of Substantially Equivalent on June 23, 2010. 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.