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

    OPTIMAX/ COMPACT 2

    K Number: K992818 · Decision Sep 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    2
    Review Days
    12

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    Basic Information

    Device Name
    OPTIMAX/ COMPACT 2
    K Number
    K992818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Protec GmbH & Co. KG
    Date Received
    August 20, 1999
    Decision Date
    September 1, 1999
    Product Code
    IXW
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    IXW Processor, Radiographic-Film, Automatic

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