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

    SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE

    K Number: K861463 · Decision May 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    236
    Applicant Total
    174
    Review Days
    15

    Basic Information

    Device Name
    SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
    K Number
    K861463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    SHILEY, INC.
    Date Received
    April 21, 1986
    Decision Date
    May 6, 1986
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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