510(k) K880479

IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP by Imed Corp. — Product Code FRN

K880479 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on April 25, 1988. 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.