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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K010436
Device Name TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011
Applicant
Remote Diagnostic Technologies , Ltd.
The Ave., Farleigh Wallop
Basingstoke, Hampshire,  GB RG25 2HT
Applicant Contact CHRIS HANNAN
Correspondent
Remote Diagnostic Technologies , Ltd.
The Ave., Farleigh Wallop
Basingstoke, Hampshire,  GB RG25 2HT
Correspondent Contact CHRIS HANNAN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/13/2001
Decision Date 05/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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