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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(With Arrhythmia Detection Or Alarms)
510(k) Number K170567
Device Name Tempus Pro Patient Monitor
Applicant
Remote Diagnostic Technologies , Ltd.
Pavilion C2, Ashwood Park, Ashwood Way
Basingstoke,  GB RG23 8BG
Applicant Contact Chris Hannan
Correspondent
Remote Diagnostic Technologies , Ltd.
Pavilion C2, Ashwood Park, Ashwood Way
Basingstoke,  GB RG23 8BG
Correspondent Contact Chris Hannan
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/27/2017
Decision Date 07/06/2017
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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