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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 K980533
Device Name ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
Applicant
ETYMOTIC RESEARCH
511 SILVER LAKE DR.
DANVILLE,  CA  94526
Applicant Contact KRISTA M BUCKLES, M.A.
Correspondent
ETYMOTIC RESEARCH
511 SILVER LAKE DR.
DANVILLE,  CA  94526
Correspondent Contact KRISTA M BUCKLES, M.A.
Regulation Number874.1050
Classification Product Code
EWO  
Date Received02/11/1998
Decision Date 03/23/1998
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
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