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

    Emory Cardiac Toolbox 4.3

    K Number: K223422 · Decision Mar 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    2
    Review Days
    136

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    Basic Information

    Device Name
    Emory Cardiac Toolbox 4.3
    K Number
    K223422
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntermed
    Date Received
    November 14, 2022
    Decision Date
    March 30, 2023
    Product Code
    KPS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Syntermed

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