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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, Group And Auditory Trainer
510(k) Number K821691
Device Name STIMRITE
Applicant
BIOTONE INTERNATIONAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOTONE INTERNATIONAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.3320
Classification Product Code
EPF  
Date Received06/08/1982
Decision Date 08/25/1982
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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