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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 K201746
Device Name Tempus Pro Patient Monitor
Applicant
Remote Diagnostic Technologies Limited
Pavilion C2, Ashwood Park, Ashwood Way
Basingstoke,  GB RG23 8BG
Applicant Contact Timothy Bubb
Correspondent
Philips North America, LLC
22100 Bothell Everett Highway
Bothell,  WA  98021
Correspondent Contact Neha Hardiya
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DPS   DQA   DRG   DRT  
DSB   DSK   DXN   FLL   ITX   IYO  
MNR   MWI  
Date Received06/26/2020
Decision Date 09/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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