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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 K013977
Device Name ECHO-SCREEN T, TA, TD, TDA, TC
Applicant
Fischer-Zoth Audiologic Systems, Inc.
1257 W. Margaret View Circle
Riverton,  UT  84065
Applicant Contact MICHAEL SOERENSEN
Correspondent
Fischer-Zoth Audiologic Systems, Inc.
1257 W. Margaret View Circle
Riverton,  UT  84065
Correspondent Contact MICHAEL SOERENSEN
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received12/03/2001
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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