510(k) K091336

IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V by Enthermics Medical Systems, Inc. — Product Code LGZ

K091336 is an FDA 510(k) premarket notification submitted by Enthermics Medical Systems, Inc. for the device "IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V". The FDA issued a decision of Substantially Equivalent on May 7, 2010. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Enthermics Medical Systems, Inc. has at least 3 other 510(k) clearances on record.