510(k) K133647

EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM by Eps Bio Technology Corp. — Product Code NBW

K133647 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 27, 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.