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Bio-Logic Systems Corp.
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BIO-LOGIC INSERT EARPHONES is an FDA 510(k)-cleared medical device (K031352) manufactured by Bio-Logic Systems Corp.. 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 July 15, 2003. Regulation: 8.

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