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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 K133988
Device Name TEMPUS PRO EXTENDED FEATURES
Applicant
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
THE OLD COACH HOUSE, THE AV.
FARLEIGH WALLOP, BASINGSTOKE
HAMPSHIRE,  GB RG25 2HT
Applicant Contact LEIGH CORNOCK
Correspondent
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
THE OLD COACH HOUSE, THE AV.
FARLEIGH WALLOP, BASINGSTOKE
HAMPSHIRE,  GB RG25 2HT
Correspondent Contact LEIGH CORNOCK
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
CCK   DPS   DRT   DSB   DXN  
Date Received12/26/2013
Decision Date 05/16/2014
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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