BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1— 510(k) K864823

Name: FDA 510(k) clearance K864823
Creator: U.S. Food and Drug Administration
Published: 1987-01-06

Substantially Equivalent

Bernafon, Inc.

FDA 510(k) clearance K864823 for BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1, Substantially Equivalent on 1987-01-06. 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: 1986-12-09
Decision date: 1987-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountainside, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.