MODIFIED HEARING AID (IN-THE-EAR)— 510(k) K902487

Name: FDA 510(k) clearance K902487
Creator: U.S. Food and Drug Administration
Published: 1990-10-09

Substantially Equivalent

Audio Hearing Aid Service

FDA 510(k) clearance K902487 for MODIFIED HEARING AID (IN-THE-EAR), Substantially Equivalent on 1990-10-09. Applicant: Audio Hearing Aid Service. Device class: 1.

Clearance details

Applicant: Audio Hearing Aid Service
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1990-06-01
Decision date: 1990-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, OH, US

Download summary PDF View on FDA.gov ↗

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