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

    DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004

    K Number: K921501 · Decision May 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    28
    Applicant Total
    20
    Review Days
    45

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    Basic Information

    Device Name
    DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004
    K Number
    K921501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biodan Medical Systems, Ltd.
    Date Received
    March 31, 1992
    Decision Date
    May 15, 1992
    Product Code
    IZZ
    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
    IZZ Table, Radiographic, Non-Tilting, Powered

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