510(k) K150910

ACCU-CHEK Connect Diabetes Management App by Roche Diabetes Care, Inc. — Product Code NDC

K150910 is an FDA 510(k) premarket notification submitted by Roche Diabetes Care, Inc. for the device "ACCU-CHEK Connect Diabetes Management App". The FDA issued a decision of Substantially Equivalent on June 3, 2015. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Roche Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.