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

    AMICI XENON REBREATHING SYSTEM*

    K Number: K865084 · Decision Mar 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    47
    Applicant Total
    8
    Review Days
    63

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AMICI XENON REBREATHING SYSTEM*
    K Number
    K865084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Amici, Inc.
    Date Received
    December 30, 1986
    Decision Date
    March 3, 1987
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IYT), ordered by most recent decision date.

    Patient Administration Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    XENON CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    XENON GAS BREATHING CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    XENON CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    TETLEY PATIENT ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    BOLUS XENON CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Amici, Inc.

    K Number Device Name
    K063716 AEROSOL SYSTEM
    K952910 THE SWIRLER NEBULIZER
    K952893 THE SWIRLER AEROSOL SYSTEM
    K903805 AMICI XENON ADMINISTRATION SET
    K904684 AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION
    K903694 AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE
    K872920 AMICI KRYPTON ADMINISTRATION SYSTEM*