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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K083630
Device Name CLUE MEDICAL AND CLUE MEDICAL BASIC
Applicant
Telovital GmbH Telemedizin
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact CHERITA JAMES
Correspondent
Telovital GmbH Telemedizin
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact CHERITA JAMES
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DPS  
Date Received12/08/2008
Decision Date 04/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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