510(k) K950419

THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS by Imed Corp. — Product Code FRN

K950419 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS". The FDA issued a decision of Substantially Equivalent on June 21, 1995. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Imed Corp. has at least 10 other 510(k) clearances on record.