510(k) K212248

GlucoLeader Enhance 2 Blood Glucose Monitoring System by Hmd Biomedical, Inc. — Product Code NBW

K212248 is an FDA 510(k) premarket notification submitted by Hmd Biomedical, Inc. for the device "GlucoLeader Enhance 2 Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on August 29, 2022. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Hmd Biomedical, Inc. has at least 10 other 510(k) clearances on record.