510(k) K133389

EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM by Eps Bio Technology Corp. — Product Code NBW

K133389 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 15, 2014. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Eps Bio Technology Corp. has at least 10 other 510(k) clearances on record.