IE-ZEN (IN CLEAR SERIES HEARING AID)— 510(k) K110973

Substantially Equivalent

Widex USA

FDA 510(k) clearance K110973 for IE-ZEN (IN CLEAR SERIES HEARING AID), Substantially Equivalent on 2011-05-05. Applicant: Widex USA. Device class: 2.

Clearance details

Applicant: Widex USA
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2011-04-06
Decision date: 2011-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Lisle, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.