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

    FACTS MONOBLOCK

    K Number: K981267 · Decision May 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    FACTS MONOBLOCK
    K Number
    K981267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dynarad Corp.
    Date Received
    April 7, 1998
    Decision Date
    May 6, 1998
    Product Code
    IZX
    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
    IZX Collimator, Manual, Radiographic

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