510(k) K112370

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM by Welldoc, Inc. — Product Code MRZ

K112370 is an FDA 510(k) premarket notification submitted by Welldoc, Inc. for the device "WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM". The FDA issued a decision of Substantially Equivalent on October 14, 2011. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Welldoc, Inc. has at least 10 other 510(k) clearances on record.