audifon Tinnitus-Module— 510(k) K171243

Substantially Equivalent

Audiofon USA, Inc.

FDA 510(k) clearance K171243 for audifon Tinnitus-Module, Substantially Equivalent on 2017-10-19. Applicant: Audiofon USA, Inc..

Clearance details

Applicant: Audiofon USA, Inc.
Product code: Code KLW
Advisory panel: Ear, Nose, Throat
Date received: 2017-04-28
Decision date: 2017-10-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Debary, FL, US

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