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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 K050670
Device Name SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS
Applicant
TMS TELEMEDIZINISCHE SYSTEME GMBH
STADLERSTRASSE 14
CHEMNITZ,  DE 09126
Applicant Contact TILO BORCHARDT
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact WILLIAM J SAMMONS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received03/15/2005
Decision Date 03/30/2005
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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