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

    VERSATOME

    K Number: K771549 · Decision Aug 25, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    41
    Applicant Total
    5
    Review Days
    13

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    Basic Information

    Device Name
    VERSATOME
    K Number
    K771549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1740
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Kermath Mfg. Corp.
    Date Received
    August 12, 1977
    Decision Date
    August 25, 1977
    Product Code
    IZF
    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
    IZF System, X-Ray, Tomographic

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