510(k) K955231

MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP by Medex, Inc. — Product Code FRN

K955231 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP". The FDA issued a decision of ST on July 18, 1996. 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.