510(k) K022203

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 by Abbott Laboratories — Product Code MEA

K022203 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384". The FDA issued a decision of Substantially Equivalent on August 1, 2002. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Abbott Laboratories has at least 10 other 510(k) clearances on record.