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Earlogic Corporation
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EARLOGIC OAE TESTER is an FDA 510(k)-cleared medical device (K112992) manufactured by Earlogic Corporation. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 2012. Regulation: 8.

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