510(k) K111386

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) by Smiths Medical MD, Inc. — Product Code FRN

K111386 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)". The FDA issued a decision of Substantially Equivalent on August 29, 2011. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.