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

    TRACHEAL TUBE 16 GAUGE-1.65MM-

    K Number: K832466 · Decision Sep 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    5
    Review Days
    421

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    Basic Information

    Device Name
    TRACHEAL TUBE 16 GAUGE-1.65MM-
    K Number
    K832466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Erie Medical
    Date Received
    July 26, 1983
    Decision Date
    September 19, 1984
    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 Erie Medical

    K Number Device Name
    K861865 ERIE-NEB
    K853051 TRACHEAL TUBES
    K853039 PRESSURE REGULATOR
    K853040 PRESSURE GAUGE