510(k) K100066

DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 by Welldoc, Inc. — Product Code MRZ

K100066 is an FDA 510(k) premarket notification submitted by Welldoc, Inc. for the device "DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1". The FDA issued a decision of Substantially Equivalent on July 15, 2010. 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.