510(k) K953896

THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS by Imed Corp. — Product Code FRN

K953896 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS". The FDA issued a decision of Substantially Equivalent on March 20, 1996. 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.