BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    AMADEO M-DR mini, AMADEO M-AX mini

    K Number: K182317 · Decision Sep 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    AMADEO M-DR mini, AMADEO M-AX mini
    K Number
    K182317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oehm Und Rehbein GmbH
    Date Received
    August 27, 2018
    Decision Date
    September 24, 2018
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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