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

    HUESTIS COMPU-FORMER

    K Number: K880047 · Decision Apr 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    50
    Applicant Total
    6
    Review Days
    96

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    Basic Information

    Device Name
    HUESTIS COMPU-FORMER
    K Number
    K880047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Huestis Machine Corp.
    Date Received
    January 6, 1988
    Decision Date
    April 11, 1988
    Product Code
    IXI
    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
    IXI Block, Beam-Shaping, Radiation Therapy

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    Other Clearances by Huestis Machine Corp.

    K Number Device Name
    K940145 COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE
    K926187 POSICAST IMMOBILIZATION SYSTEM
    K904005 HUESTIS FLEXI-BOARD
    K901567 THE HUESTIS COMPU-PLOTTER
    K792721 HUESTIS FLEXI-HOLDER