510(k) K190189

MDT2 BLE Self-Monitoring Blood Glucose System by Eps Bio Technology Corp. — Product Code NBW

K190189 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "MDT2 BLE Self-Monitoring Blood Glucose System". The FDA issued a decision of Substantially Equivalent on November 1, 2019. 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.