BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    JEE FRAME (VENTILATOR CIRCUIT SUPPORT)

    K Number: K850924 · Decision Jul 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    136

    Basic Information

    Device Name
    JEE FRAME (VENTILATOR CIRCUIT SUPPORT)
    K Number
    K850924
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5280
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    VULCAN LABORATORIES, INC.
    Date Received
    March 5, 1985
    Decision Date
    July 19, 1985
    Product Code
    JAY
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAY Support, Breathing Tube

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