TEMPUSIC PATIENT MONITOR

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

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 IDK113105
510k NumberK113105
Device Name:TEMPUSIC PATIENT MONITOR
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE OLD COACH HOUSE, THE AV. FARLEIGH WALLOP, BASINGSTOKE Hampshire,  GB Rg25 2ht
ContactChris Hannan
CorrespondentWilliam Sammons
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-10-20
Decision Date2011-12-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060472440709 K113105 000
05060472440693 K113105 000
05060472440686 K113105 000
05060472440679 K113105 000
05060472440600 K113105 000

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