510(k) K160430

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

K160430 is an FDA 510(k) premarket notification submitted by Ascensia Diabetes Care U.S., Inc. for the device "Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on June 24, 2016. 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.