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

    AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION

    K Number: K904684 · Decision Jan 14, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    47
    Applicant Total
    8
    Review Days
    152

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    Basic Information

    Device Name
    AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION
    K Number
    K904684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Amici, Inc.
    Date Received
    August 15, 1990
    Decision Date
    January 14, 1991
    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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