
Agamatrix
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WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 is an FDA 510(k)-cleared medical device (K101597) manufactured by Agamatrix. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 17, 2010. Regulation: 8.