INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR— 510(k) K872647

Name: FDA 510(k) clearance K872647
Creator: U.S. Food and Drug Administration
Published: 1987-08-26

Substantially Equivalent

Int'L Hearing Aids, Inc.

FDA 510(k) clearance K872647 for INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR, Substantially Equivalent on 1987-08-26. 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: 1987-07-07
Decision date: 1987-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

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