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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 K051471
Device Name CARDIODAY
Applicant
Getemed Medizin- Und Informationstechnik AG
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact BERT SCHADOW
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/03/2005
Decision Date 06/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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