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

    MTX GENERATOR

    K Number: K880352 · Decision Jul 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    190
    Review Days
    170

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    Basic Information

    Device Name
    MTX GENERATOR
    K Number
    K880352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    January 26, 1988
    Decision Date
    July 14, 1988
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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