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

    CUFF BARO GUARD OR CBG ABBREVIATED

    K Number: K901255 · Decision Mar 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    13

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    Basic Information

    Device Name
    CUFF BARO GUARD OR CBG ABBREVIATED
    K Number
    K901255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5750
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Nelson Engineering, Inc.
    Date Received
    March 15, 1990
    Decision Date
    March 28, 1990
    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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