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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K103678
Device Name CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
MUNZINGER STRASSE 5
FREIBURG,BADEN WURTTEMBERG,  DE 79111
Applicant Contact ALBRECHT MALKMUS
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
MUNZINGER STRASSE 5
FREIBURG,BADEN WURTTEMBERG,  DE 79111
Correspondent Contact ALBRECHT MALKMUS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/16/2010
Decision Date 02/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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