510(k) K933144

GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER by Imed Corp. — Product Code FRN

K933144 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER". The FDA issued a decision of Substantially Equivalent on October 12, 1993. 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.