Tempus Pro Patient Monitor

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Remote Diagnostic Technologies Limited

The following data is part of a premarket notification filed by Remote Diagnostic Technologies Limited with the FDA for Tempus Pro Patient Monitor.

Pre-market Notification Details

Device IDK201746
510k NumberK201746
Device Name:Tempus Pro Patient Monitor
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Remote Diagnostic Technologies Limited Pavilion C2, Ashwood Park, Ashwood Way Basingstoke,  GB Rg23 8bg
ContactTimothy Bubb
CorrespondentNeha Hardiya
Philips North America LLC 22100 Bothell Everett Highway Bothell,  WA  98021
Product CodeMHX  
Subsequent Product CodeCCK
Subsequent Product CodeDPS
Subsequent Product CodeDQA
Subsequent Product CodeDRG
Subsequent Product CodeDRT
Subsequent Product CodeDSB
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeMNR
Subsequent Product CodeMWI
Subsequent Product CodeNSX
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-26
Decision Date2020-09-18

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