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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 K173768
Device Name Tempus Pro Patient Monitor
Applicant
Remote Diagnostic Technologies Ltd.
Pavilion C2, Ashwood Park, Ashwood Way
Basingstoke,  GB RG23 8BG
Applicant Contact James Hamlyn
Correspondent
Remote Diagnostic Technologies Ltd.
Pavilion C2, Ashwood Park, Ashwood Way
Basingstoke,  GB RG23 8BG
Correspondent Contact James Hamlyn
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DPS   DQA   DRG   DRT  
DSB   DSK   DXN   FFL   ITX   IYO  
MNR   MWI  
Date Received12/11/2017
Decision Date 01/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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