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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K812938
Device Name IN-THE-EAR MODEL 821
Applicant
DANAVOX, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DANAVOX, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/20/1981
Decision Date 11/06/1981
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
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