K-numberK171751
Device nameSmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module
ApplicantCapsule Technologie Sas
Product codeMWI
Device classClass II
Decision dateOct 24, 2017
DecisionSubstantially Equivalent
Regulation870.2300
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