510(k) K895797

IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE by Imed Corp. — Product Code FRN

K895797 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE". The FDA issued a decision of Substantially Equivalent on January 2, 1990. 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.