510(k) K051253

MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) by Baxter Healthcare Corp — Product Code MEA

K051253 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)". The FDA issued a decision of Substantially Equivalent on July 15, 2005. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.