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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name masker, tinnitus
510(k) Number K110973
Device Name IE-ZEN (IN CLEAR SERIES HEARING AID)
Applicant
WIDEX USA
2300 CABOT DRIVE, SUITE 415
LISLE,  IL  60532
Applicant Contact FRANCIS KUK
Correspondent
WIDEX USA
2300 CABOT DRIVE, SUITE 415
LISLE,  IL  60532
Correspondent Contact FRANCIS KUK
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/06/2011
Decision Date 05/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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