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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 K130516
Device Name CARDIODAY
Applicant
Getemed Medizin- Und Informationstechnik AG
Oderstr. 77
Teltow, Brandenburg,  DE 14513
Applicant Contact BERT SCHADOW
Correspondent
Getemed Medizin- Und Informationstechnik AG
Oderstr. 77
Teltow, Brandenburg,  DE 14513
Correspondent Contact BERT SCHADOW
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/27/2013
Decision Date 08/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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