510(k) K111728

EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM by Eps Bio Technology Corp. — Product Code CGA

K111728 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 16, 2011. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Eps Bio Technology Corp. has at least 10 other 510(k) clearances on record.