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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 K010165
Device Name ERO SCAN OAE TEST SYSTEM
Applicant
ETYMOTIC RESEARCH
61 MARTIN LN.
ELK GROVE VILLAGE,  IL  60007
Applicant Contact STEVE ISEBERG
Correspondent
ETYMOTIC RESEARCH
61 MARTIN LN.
ELK GROVE VILLAGE,  IL  60007
Correspondent Contact STEVE ISEBERG
Regulation Number874.1050
Classification Product Code
EWO  
Date Received01/18/2001
Decision Date 03/12/2001
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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