510(k) K062555

EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G by Visgeneer, Inc. — Product Code NBW

K062555 is an FDA 510(k) premarket notification submitted by Visgeneer, Inc. for the device "EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G". The FDA issued a decision of Substantially Equivalent on December 27, 2006. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Visgeneer, Inc. has at least 2 other 510(k) clearances on record.