BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    Task Force CORE

    K Number: K223332 · Decision Apr 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    2
    Review Days
    163

    Basic Information

    Device Name
    Task Force CORE
    K Number
    K223332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CNSystems Medizintechnik GmbH
    Date Received
    October 31, 2022
    Decision Date
    April 12, 2023
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by CNSystems Medizintechnik GmbH

    K Number Device Name
    K183521 CNAP Monitor