BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇩🇰 Denmark

    CADScor System

    K Number: DEN190047 · Decision Nov 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    386

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    Basic Information

    Device Name
    CADScor System
    K Number
    DEN190047
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.1420
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Acarix A/S
    Date Received
    November 4, 2019
    Decision Date
    November 24, 2020
    Product Code
    QMW
    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
    QMW Coronary Artery Disease Risk Indicator From Acoustic Heart Signals