
Frye Electronics, Inc.
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FONIX ,MODEL 8000 is an FDA 510(k)-cleared medical device (K093006) manufactured by Frye Electronics, 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 December 29, 2009. Regulation: 8.

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