510(k) K141829

GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM by Ceragem Medisys, Inc. — Product Code NBW

K141829 is an FDA 510(k) premarket notification submitted by Ceragem Medisys, Inc. for the device "GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 24, 2014. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Ceragem Medisys, Inc. has at least 3 other 510(k) clearances on record.