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

    DISPENSOR, XENON GAS

    K Number: K781933 · Decision Dec 4, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    DISPENSOR, XENON GAS
    K Number
    K781933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Isotapes, Inc.
    Date Received
    November 20, 1978
    Decision Date
    December 4, 1978
    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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