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

    SPECTRUM X-RAY CORP

    K Number: K834494 · Decision Feb 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    28
    Applicant Total
    9
    Review Days
    69

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    Basic Information

    Device Name
    SPECTRUM X-RAY CORP
    K Number
    K834494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Spectrum X-Ray Corp.
    Date Received
    December 14, 1983
    Decision Date
    February 21, 1984
    Product Code
    IZZ
    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
    IZZ Table, Radiographic, Non-Tilting, Powered

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