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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, auditory, evoked response
510(k) Number K141446
Device Name ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
Applicant
NATUS MEDICAL INCORPORATED
5900 FIRST AVENUE SOUTH
SEATTLE,  WA  98108
Applicant Contact JUDY BUCKHAM
Correspondent
NATUS MEDICAL INCORPORATED
5900 FIRST AVENUE SOUTH
SEATTLE,  WA  98108
Correspondent Contact JUDY BUCKHAM
Regulation Number882.1900
Classification Product Code
GWJ  
Subsequent Product Code
EWO  
Date Received06/02/2014
Decision Date 08/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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