INT'L MODEL XG BEHIND-THE-EAR HEARING AID— 510(k) K853941

Name: FDA 510(k) clearance K853941
Creator: U.S. Food and Drug Administration
Published: 1985-12-18

Substantially Equivalent

Int'L Hearing Aids, Inc.

FDA 510(k) clearance K853941 for INT'L MODEL XG BEHIND-THE-EAR HEARING AID, Substantially Equivalent on 1985-12-18. Applicant: Int'L Hearing Aids, Inc.. Device class: 1.

Clearance details

Applicant: Int'L Hearing Aids, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1985-09-24
Decision date: 1985-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

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