510(k) K091820

CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM by Bayer Healthcare — Product Code NBW

K091820 is an FDA 510(k) premarket notification submitted by Bayer Healthcare for the device "CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 26, 2009. 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.