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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 WEST MARGARET VIEW CIRCLE
RIVERTON,  UT  84065
Applicant Contact MICHAEL SOERENSEN
Correspondent
FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC.
1257 WEST 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
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