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Optima Neuroscience, Inc.
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IDENTEVENT, VERSION 1.0G is an FDA 510(k)-cleared medical device (K092039) manufactured by Optima Neuroscience, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 2009. Regulation: 8.