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

    TRACHEA/CUFF INFLATOR W/PRESSURE #583

    K Number: K831577 · Decision Jul 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    51

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    Basic Information

    Device Name
    TRACHEA/CUFF INFLATOR W/PRESSURE #583
    K Number
    K831577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5750
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Electronics Corp.
    Date Received
    May 17, 1983
    Decision Date
    July 7, 1983
    Product Code
    BSK
    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
    BSK Cuff, Tracheal Tube, Inflatable

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