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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 K770938
Device Name TINNITUS AID, MODEL S244
Applicant
Vicon Instrument Co.
MD 
Correspondent
Vicon Instrument Co.
MD 
Regulation Number874.3400
Classification Product Code
KLW  
Date Received05/23/1977
Decision Date 06/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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