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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K070614
Device Name CORSCREEN
Applicant
VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG,  DE 97204
Applicant Contact DETLEF GROTHEER
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/05/2007
Decision Date 05/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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