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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 K150171
Device Name Tinnitus Sound Generator Module
Applicant
GN RESOUND A/S
LAUTRUPBJERG 7
BALLERUP,  DK DK-2750
Applicant Contact Lars Hagander
Correspondent
GN RESOUND A/S
LAUTRUPBJERG 7
BALLERUP,  DK DK-2750
Correspondent Contact Lars Hagander
Regulation Number874.3400
Classification Product Code
KLW  
Date Received01/26/2015
Decision Date 05/14/2015
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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