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

    SENTEC LASER GUIDE LINE, MODEL SGL-05

    K Number: K862340 · Decision Jul 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    21

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    Basic Information

    Device Name
    SENTEC LASER GUIDE LINE, MODEL SGL-05
    K Number
    K862340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Sentec Corp.
    Date Received
    June 20, 1986
    Decision Date
    July 11, 1986
    Product Code
    IZW
    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
    IZW Collimator, Automatic, Radiographic

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