
Audiofon USA, Inc.
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audifon Tinnitus-Module is an FDA 510(k)-cleared medical device (K171243) manufactured by Audiofon USA, 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 October 18, 2017. Regulation: 8.

Ansell
SKU MSC846624

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SKU VM-1270031