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

    FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES

    K Number: K862267 · Decision Jun 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    50
    Review Days
    5

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    Basic Information

    Device Name
    FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
    K Number
    K862267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bivona Medical Technologies
    Date Received
    June 13, 1986
    Decision Date
    June 18, 1986
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Bivona Medical Technologies

    K Number Device Name
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