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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 K003364
Device Name VIVO 200 DPS VIVOSCAN
Applicant
VIVOSONIC, INC.
1151 HOPE ST.
STAMFORD,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
VIVOSONIC, INC.
1151 HOPE ST.
STAMFORD,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/27/2000
Decision Date 07/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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