510(k) K191286

CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System by Ascensia Diabetes Care — Product Code NBW

K191286 is an FDA 510(k) premarket notification submitted by Ascensia Diabetes Care for the device "CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on November 8, 2019. 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 has at least 5 other 510(k) clearances on record.