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

    XENON CIRCUIT

    K Number: K914747 · Decision Feb 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    47
    Applicant Total
    15
    Review Days
    128

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    Basic Information

    Device Name
    XENON CIRCUIT
    K Number
    K914747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gibeck, Inc.
    Date Received
    October 22, 1991
    Decision Date
    February 27, 1992
    Product Code
    IYT
    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
    IYT System, Rebreathing, Radionuclide

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