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

    AIRE-CUF TRACHEOSTOMY TUBE

    K Number: K812163 · Decision Sep 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    1
    Review Days
    54

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    Basic Information

    Device Name
    AIRE-CUF TRACHEOSTOMY TUBE
    K Number
    K812163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bioana Surgical Instruments, Inc.
    Date Received
    July 29, 1981
    Decision Date
    September 21, 1981
    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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