BEHIND THE EAR HEARING AIDS BERNAFON X-13— 510(k) K844425

Name: FDA 510(k) clearance K844425
Creator: U.S. Food and Drug Administration
Published: 1985-01-04

Substantially Equivalent

Bernafon, Inc.

FDA 510(k) clearance K844425 for BEHIND THE EAR HEARING AIDS BERNAFON X-13, Substantially Equivalent on 1985-01-04. Applicant: Bernafon, Inc.. Device class: 1.

Clearance details

Applicant: Bernafon, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1984-11-15
Decision date: 1985-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountainside, NJ, US

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