510(k) K182057

EasyMax BT Self-Monitoring Blood Glucose System by Eps Bio Technology Corp. — Product Code NBW

K182057 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "EasyMax BT Self-Monitoring Blood Glucose System". The FDA issued a decision of Substantially Equivalent on August 24, 2018. 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.