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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 K982642
Device Name ECHO-SCREEN
Applicant
Fischer-Zoth Audiologic Systems, Inc.
11309 Brandon Park Dr., #B
Sandy,  UT  84092
Applicant Contact DAVID G WOOD
Correspondent
Fischer-Zoth Audiologic Systems, Inc.
11309 Brandon Park Dr., #B
Sandy,  UT  84092
Correspondent Contact DAVID G WOOD
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/29/1998
Decision Date 10/21/1998
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
Predetermined Change
Control Plan Authorized		 No
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