510(k) K921378

IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE by Imed Corp. — Product Code FRN

K921378 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE". The FDA issued a decision of Substantially Equivalent on June 9, 1992. 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.