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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 K151013
Device Name Vitaphone Tele ECG Loop Recorder
Applicant
Vitasystems GmbH
Stadlerstrasse 14
Chemnitz,  DE D-09126
Applicant Contact Michael Rothhaar
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/15/2015
Decision Date 04/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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