ZEN PROGRAM (MIND 440 HEARING AID)— 510(k) K080955

Name: FDA 510(k) clearance K080955
Creator: U.S. Food and Drug Administration
Published: 2008-06-27

Substantially Equivalent

Widex Hearing Aid Co., Inc.

FDA 510(k) clearance K080955 for ZEN PROGRAM (MIND 440 HEARING AID), Substantially Equivalent on 2008-06-27. Applicant: Widex Hearing Aid Co., Inc.. Device class: 2.

Clearance details

Applicant: Widex Hearing Aid Co., Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2008-04-03
Decision date: 2008-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, US

Download summary PDF View on FDA.gov ↗

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