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Amplivox, Ltd.
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AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER is an FDA 510(k)-cleared medical device (K081841) manufactured by Amplivox, Ltd.. 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, 2008. Regulation: 8.

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