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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K152124
Device Name Tempus IC2
Applicant
Remote Diagnostics Technologies, Ltd.
The Old Coach House, The Ave., Farleigh Wallop
Basingstoke,  GB RG25 2HT
Applicant Contact CHRIS HANNAN
Correspondent
Remote Diagnostics Technologies, Ltd.
The Old Coach House, The Ave., Farleigh Wallop
Basingstoke,  GB RG25 2HT
Correspondent Contact CHRIS HANNAN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/31/2015
Decision Date 10/28/2015
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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