510(k) K083265

JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 by Agamatrix, Inc. — Product Code NBW

K083265 is an FDA 510(k) premarket notification submitted by Agamatrix, Inc. for the device "JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381". The FDA issued a decision of Substantially Equivalent on February 3, 2009. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Agamatrix, Inc. has at least 10 other 510(k) clearances on record.