
Handtronix, Inc.
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OTOSCREENER-I AND OTO-SCREEN-I-P is an FDA 510(k)-cleared medical device (K903143) manufactured by Handtronix, Inc.. 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 September 18, 1990. Regulation: 8.

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