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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 K033108
Device Name VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
Applicant
VIVOSONIC, INC.
56 ABERFOYLE CRESCENT
SUITE 620
TORONTO, ON,  CA M8X 2W4
Applicant Contact YURI SOKOLOV
Correspondent
VIVOSONIC, INC.
56 ABERFOYLE CRESCENT
SUITE 620
TORONTO, ON,  CA M8X 2W4
Correspondent Contact YURI SOKOLOV
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/30/2003
Decision Date 10/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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