Tempus LS - Manual

Dc-defibrillator, Low-energy, (including Paddles)

Remote Diagnostic Technologies, Ltd, A Philips Company

The following data is part of a premarket notification filed by Remote Diagnostic Technologies, Ltd, A Philips Company with the FDA for Tempus Ls - Manual.

Pre-market Notification Details

Device IDK200849
510k NumberK200849
Device Name:Tempus LS - Manual
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant Remote Diagnostic Technologies, Ltd, A Philips Company Pavilion C2, Ashwood Park, Ashwood Way Basingstoke,  GB Rg23 8bg
ContactMartin Newman
CorrespondentMeaghan Bailey
NSF Health Sciences, LLC 2001 Pennsylvania Avenue NW, Suite 950 Washington,  DC  20006
Product CodeLDD  
Subsequent Product CodeDPS
Subsequent Product CodeDRO
Subsequent Product CodeLIX
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-07-24

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