FACEPLATE ITE HEARING AID MODEL 28A— 510(k) K910901

Name: FDA 510(k) clearance K910901
Creator: U.S. Food and Drug Administration
Published: 1991-05-30

Substantially Equivalent

Telex Communications, Inc.

FDA 510(k) clearance K910901 for FACEPLATE ITE HEARING AID MODEL 28A, Substantially Equivalent on 1991-05-30. Applicant: Telex Communications, Inc.. Device class: 1.

Clearance details

Applicant: Telex Communications, Inc.
Product code: Code LRB
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1991-03-05
Decision date: 1991-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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