TEMPUSIC PATIENT MONITOR

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 Tempusic Patient Monitor.

Pre-market Notification Details

Device IDK082718
510k NumberK082718
Device Name:TEMPUSIC PATIENT MONITOR
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE AVENUE, FARLEIGH WALLOP Basingstoke, Hampshire,  GB Rg25 2ht
ContactChris Hannan
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-09-17
Decision Date2008-10-10
Summary:summary

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