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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 K100383
Device Name VITAPHONE. MODEL 100 BT
Applicant
Vitasystems GmbH
Stadlerstrasse 14
Chemnitz,  DE 09126
Applicant Contact TILO BORCHARDT
Correspondent
Vitasystems GmbH
Stadlerstrasse 14
Chemnitz,  DE 09126
Correspondent Contact TILO BORCHARDT
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/16/2010
Decision Date 04/20/2010
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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