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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K884046
Device Name AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
Applicant
Etymonic Design, Inc.
41 Byron Ave.
Dorchester, Ontario,  CA NOL 1GO
Applicant Contact COLE
Correspondent
Etymonic Design, Inc.
41 Byron Ave.
Dorchester, Ontario,  CA NOL 1GO
Correspondent Contact COLE
Regulation Number874.3310
Classification Product Code
ETW  
Date Received09/26/1988
Decision Date 02/13/1989
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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