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

    CLARK PRECISION BLOCK CUTTER, COOLING

    K Number: K842615 · Decision Sep 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    61

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    Basic Information

    Device Name
    CLARK PRECISION BLOCK CUTTER, COOLING
    K Number
    K842615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Clark Research and Development, Inc.
    Date Received
    July 5, 1984
    Decision Date
    September 4, 1984
    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 Clark Research and Development, Inc.

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    K954589 CLARK TUT IMAGE PROCESSING SYSTEM