AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID— 510(k) K874384

Name: FDA 510(k) clearance K874384
Creator: U.S. Food and Drug Administration
Published: 1988-01-19

Substantially Equivalent

Audiotone, Inc.

FDA 510(k) clearance K874384 for AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID, Substantially Equivalent on 1988-01-19. Applicant: Audiotone, Inc.. Device class: 1.

Clearance details

Applicant: Audiotone, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1987-10-26
Decision date: 1988-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, 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.