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

    COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE

    K Number: K940145 · Decision Jan 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    6
    Review Days
    386

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    Basic Information

    Device Name
    COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE
    K Number
    K940145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Huestis Machine Corp.
    Date Received
    January 3, 1994
    Decision Date
    January 24, 1995
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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    Other Clearances by Huestis Machine Corp.

    K Number Device Name
    K926187 POSICAST IMMOBILIZATION SYSTEM
    K904005 HUESTIS FLEXI-BOARD
    K901567 THE HUESTIS COMPU-PLOTTER
    K880047 HUESTIS COMPU-FORMER
    K792721 HUESTIS FLEXI-HOLDER