510(k) K081905

ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP by Westmed, Inc. — Product Code MEB

K081905 is an FDA 510(k) premarket notification submitted by Westmed, Inc. for the device "ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on July 15, 2008. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Westmed, Inc. has at least 7 other 510(k) clearances on record.