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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hospital Cardiac Telemetry
510(k) Number K133973
Device Name TEMPUS PRO WITH ENHANCED FEATURES
Applicant
Remote Diagnostic Technologies , Ltd.
The Old Coach House, The Ave., Farleigh Wallop
Basingstoke,  GB RG252HT
Applicant Contact LEIGH CORNOCK
Correspondent
Remote Diagnostic Technologies , Ltd.
The Old Coach House, The Ave., Farleigh Wallop
Basingstoke,  GB RG252HT
Correspondent Contact LEIGH CORNOCK
Regulation Number870.1025
Classification Product Code
QYW  
Subsequent Product Code
MHX  
Date Received12/26/2013
Decision Date 08/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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