510(k) K002705

EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 by Baxa Corp. — Product Code LHI

K002705 is an FDA 510(k) premarket notification submitted by Baxa Corp. for the device "EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400". The FDA issued a decision of Substantially Equivalent on March 28, 2001. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Baxa Corp. has at least 7 other 510(k) clearances on record.