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

    VENTICIS II

    K Number: K863778 · Decision Oct 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    47
    Applicant Total
    9
    Review Days
    31

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    Basic Information

    Device Name
    VENTICIS II
    K Number
    K863778
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Cis-Us, Inc.
    Date Received
    September 26, 1986
    Decision Date
    October 27, 1986
    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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