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

    X-RAY GENERATING SYSTEM TF 1000

    K Number: K881386 · Decision Jul 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    7
    Review Days
    98

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    Basic Information

    Device Name
    X-RAY GENERATING SYSTEM TF 1000
    K Number
    K881386
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    General Medical Merate S.P.A
    Date Received
    April 1, 1988
    Decision Date
    July 8, 1988
    Product Code
    IZO
    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
    IZO Generator, High-Voltage, X-Ray, Diagnostic

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