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

    Dexcom Share Direct Secondary Displays

    K Number: DEN140038 · Decision Jan 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    27
    Review Days
    39

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    Basic Information

    Device Name
    Dexcom Share Direct Secondary Displays
    K Number
    DEN140038
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.1350
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Dexcom, Inc.
    Date Received
    December 15, 2014
    Decision Date
    January 23, 2015
    Product Code
    PJT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PJT Continuous Glucose Monitor Secondary Display

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