BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HOFMANN-NAGEL (HOFNA) X-RAY TUBES

    K Number: K900367 · Decision Feb 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    31

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    Basic Information

    Device Name
    HOFMANN-NAGEL (HOFNA) X-RAY TUBES
    K Number
    K900367
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1760
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Hofmann
    Date Received
    January 26, 1990
    Decision Date
    February 26, 1990
    Product Code
    ITY
    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
    ITY Assembly, Tube Housing, X-Ray, Diagnostic

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