
Medisense, Inc.
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MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM is an FDA 510(k)-cleared medical device (K901613) manufactured by Medisense, Inc.. 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 July 9, 1990. Regulation: 8.