510(k) K073573

WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM by Agamatrix — Product Code NBW

K073573 is an FDA 510(k) premarket notification submitted by Agamatrix for the device "WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 30, 2008. 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 has at least 10 other 510(k) clearances on record.