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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 K103298
Device Name ACAM 5 AUDIOMETER SYSTEM
Applicant
Acousticon GmbH
1983 Hazelwood Rd.
Toms River,  NJ  08754
Applicant Contact Maureen Garner
Correspondent
Acousticon GmbH
1983 Hazelwood Rd.
Toms River,  NJ  08754
Correspondent Contact Maureen Garner
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/08/2010
Decision Date 04/08/2011
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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