510(k) K000328

MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP by Medex, Inc. — Product Code FRN

K000328 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on May 9, 2000. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Medex, Inc. has at least 10 other 510(k) clearances on record.