510(k) K190564

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB by Bionime Corporation — Product Code NBW

K190564 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB". The FDA issued a decision of Substantially Equivalent on June 2, 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. Bionime Corporation has at least 10 other 510(k) clearances on record.