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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 K031713
Device Name AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
Applicant
Viasys Healthcare, Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Viasys Healthcare, Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWI  
Date Received06/02/2003
Decision Date 08/12/2003
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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