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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 K101264
Device Name TEMPUS IC PROFESSIONAL PATIENT MONITOR
Applicant
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
THE OLD COACH HOUSE, THE AV.
FARLEIGH WALLOP, BASINGSTOKE
HAMPSHIRE,  GB RG25 2HT
Applicant Contact CHRIS HANNAN
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number870.2300
Classification Product Code
MWI  
Date Received05/05/2010
Decision Date 05/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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