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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 K112752
Device Name TINNITUS THERAPY SYSTEM ANM T30 CR
Applicant
Anm Adaptive Neuromodulation GmbH
Im Mediapark 6d
Koln,  DE D-50670
Applicant Contact INGRID ROHM
Correspondent
Anm Adaptive Neuromodulation GmbH
Im Mediapark 6d
Koln,  DE D-50670
Correspondent Contact INGRID ROHM
Regulation Number874.3400
Classification Product Code
KLW  
Date Received09/21/2011
Decision Date 12/16/2011
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
Predetermined Change
Control Plan Authorized		 No
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