510(k) K161790

iGlucose Blood Glucose Monitoring System by Bionime Corporation — Product Code NBW

K161790 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "iGlucose Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on May 2, 2017. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Bionime Corporation has at least 10 other 510(k) clearances on record.