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

    HUESTIS FLEXI-BOARD

    K Number: K904005 · Decision Nov 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    92

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    Basic Information

    Device Name
    HUESTIS FLEXI-BOARD
    K Number
    K904005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Huestis Machine Corp.
    Date Received
    August 29, 1990
    Decision Date
    November 29, 1990
    Product Code
    JAD
    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
    JAD System, Therapeutic, X-Ray

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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
    K901567 THE HUESTIS COMPU-PLOTTER
    K880047 HUESTIS COMPU-FORMER
    K792721 HUESTIS FLEXI-HOLDER