TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011

Transmitters And Receivers, Electrocardiograph, Telephone

REMOTE DIAGNOSTIC TECHNOLOGIES LTD.

The following data is part of a premarket notification filed by Remote Diagnostic Technologies Ltd. with the FDA for Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011.

Pre-market Notification Details

Device IDK010436
510k NumberK010436
Device Name:TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE AVENUE, FARLEIGH WALLOP Basingstoke, Hampshire,  GB Rg25 2ht
ContactChris Hannan
CorrespondentChris Hannan
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE AVENUE, FARLEIGH WALLOP Basingstoke, Hampshire,  GB Rg25 2ht
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-13
Decision Date2001-05-14

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