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

    KERMATH THERAPY SIMULATOR

    K Number: K812726 · Decision Nov 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    69
    Applicant Total
    5
    Review Days
    38

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    Basic Information

    Device Name
    KERMATH THERAPY SIMULATOR
    K Number
    K812726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Kermath Mfg. Corp.
    Date Received
    September 28, 1981
    Decision Date
    November 5, 1981
    Product Code
    KPQ
    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
    KPQ System, Simulation, Radiation Therapy

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    Other Clearances by Kermath Mfg. Corp.

    K Number Device Name
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    K771549 VERSATOME