CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1

Thermometer, Electronic, Clinical

CADI SCIENTIFIC PTE.LTD

The following data is part of a premarket notification filed by Cadi Scientific Pte.ltd with the FDA for Cadi Smartsense Vital Signs And Wireless Temperature Monitori Ng System, Model S1.

Pre-market Notification Details

Device IDK083185
510k NumberK083185
Device Name:CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1
ClassificationThermometer, Electronic, Clinical
Applicant CADI SCIENTIFIC PTE.LTD S65 W35739 PIPER ROAD Eagle,  WI  53119
ContactStephen H Gorski
CorrespondentStephen H Gorski
CADI SCIENTIFIC PTE.LTD S65 W35739 PIPER ROAD Eagle,  WI  53119
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-29
Decision Date2009-03-11
Summary:summary

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