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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 K024205
Device Name AUDIOSCREENER OAE+ABR
Applicant
Everest Biomedical Instruments Co.
16690 Swingley Ridge Rd.
Suite 140
Chesterfield,  MO  63017
Applicant Contact RANDALL KROHN
Correspondent
Everest Biomedical Instruments Co.
16690 Swingley Ridge Rd.
Suite 140
Chesterfield,  MO  63017
Correspondent Contact RANDALL KROHN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received12/20/2002
Decision Date 03/07/2003
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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