510(k) K121207

EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM by Eps Bio Technology Corp. — Product Code LFR

K121207 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 18, 2012. The device falls under product code LFR (Glucose Dehydrogenase, 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.