510(k) K162336

Contour Next EZ Blood Glucose Monitoring System by Ascensia Diabetes Care U.S., Inc. — Product Code NBW

K162336 is an FDA 510(k) premarket notification submitted by Ascensia Diabetes Care U.S., Inc. for the device "Contour Next EZ Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on January 12, 2017. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Ascensia Diabetes Care U.S., Inc. has at least 6 other 510(k) clearances on record.