510(k) K062058

ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 by Bayer Healthcare — Product Code NBW

K062058 is an FDA 510(k) premarket notification submitted by Bayer Healthcare for the device "ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080". The FDA issued a decision of Substantially Equivalent on September 11, 2006. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Bayer Healthcare has at least 10 other 510(k) clearances on record.