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

    PYTON

    K Number: K092733 · Decision Feb 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    175

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    Basic Information

    Device Name
    PYTON
    K Number
    K092733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5750
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arm Medical Devices, Inc.
    Date Received
    September 4, 2009
    Decision Date
    February 26, 2010
    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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