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Vicor Technologies, Inc.
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VICOR PD2I ANALYZER, VERSION 2.1 is an FDA 510(k)-cleared medical device (K082709) manufactured by Vicor Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 2008. Regulation: 8.