BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SmartLinx 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

    K Number: K171751 · Decision Oct 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    4
    Review Days
    133

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    Basic Information

    Device Name
    SmartLinx 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
    K Number
    K171751
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Capsule Technologie Sas
    Date Received
    June 13, 2017
    Decision Date
    October 24, 2017
    Product Code
    MWI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Capsule Technologie Sas

    K Number Device Name
    K210204 Capsule Vitals Plus Patient Monitoring System
    K200856 SmartLinx Vitals Plus Patient Monitoring System
    K151071 SmartLinx Vitals Plus Patient Monitoring System