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

    XENAMATIC SERIES OF XENON REBREATH DEV

    K Number: K820571 · Decision Mar 31, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    XENAMATIC SERIES OF XENON REBREATH DEV
    K Number
    K820571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Diversified P.A.
    Date Received
    March 2, 1982
    Decision Date
    March 31, 1982
    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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    Other Clearances by Diversified P.A.

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