SEARS BEHIND-THE-EAR HEARING AID— 510(k) K800113

Name: FDA 510(k) clearance K800113
Creator: U.S. Food and Drug Administration
Published: 1980-02-11

Substantially Equivalent

Int'L Hearing Aids, Inc.

FDA 510(k) clearance K800113 for SEARS BEHIND-THE-EAR HEARING AID, Substantially Equivalent on 1980-02-11. 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: 1980-01-16
Decision date: 1980-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K872647 — INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR1987-08-26
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