ARTISAN PROGRAMMER & HEARING AID— 510(k) K935048

Name: FDA 510(k) clearance K935048
Creator: U.S. Food and Drug Administration
Published: 1994-02-09

Substantially Equivalent

Telex Communications, Inc.

FDA 510(k) clearance K935048 for ARTISAN PROGRAMMER & HEARING AID, Substantially Equivalent on 1994-02-09. 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: 1993-10-21
Decision date: 1994-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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