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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K872042
Device Name PLAYTONE AUDIOMETER
Applicant
Sensory Aids Corp.
205 W. Grand Ave.,
Suite 122
Bensenville,  IL  60106
Applicant Contact RON B MERRICK
Correspondent
Sensory Aids Corp.
205 W. Grand Ave.,
Suite 122
Bensenville,  IL  60106
Correspondent Contact RON B MERRICK
Regulation Number874.1050
Classification Product Code
EWO  
Date Received05/27/1987
Decision Date 08/11/1987
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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