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

    BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE

    K Number: K914088 · Decision Oct 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    107
    Applicant Total
    50
    Review Days
    42

    Basic Information

    Device Name
    BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
    K Number
    K914088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIVONA MEDICAL TECHNOLOGIES
    Date Received
    September 11, 1991
    Decision Date
    October 23, 1991
    Product Code
    JOH
    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
    JOH Tube Tracheostomy And Tube Cuff

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