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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 K133308
Device Name TINNITUS SOUNDSUPPORT
Applicant
OTICON A/S
KONGEBAKKEN 9
SMORUM,  DK DK-2765
Applicant Contact SOREN JUEL WITT
Correspondent
OTICON A/S
KONGEBAKKEN 9
SMORUM,  DK DK-2765
Correspondent Contact SOREN JUEL WITT
Regulation Number874.3400
Classification Product Code
KLW  
Date Received10/28/2013
Decision Date 03/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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