510(k) K913658

IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD by Imed Corp. — Product Code MEB

K913658 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD". The FDA issued a decision of Substantially Equivalent on March 26, 1992. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Imed Corp. has at least 10 other 510(k) clearances on record.