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510(k) Data Aggregation

    K Number
    DEN140016
    Device Name
    STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
    Manufacturer
    DEXCOM, INC.
    Date Cleared
    2014-08-19

    (119 days)

    Product Code
    PHV
    Regulation Number
    862.2120
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STUDIO on the Cloud Data Manager Software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities.
    Device Description
    The STUDIO on the Cloud Data Management ("STUDIO") Software is comprised of a data analysis and storage platform, report generation software, and an information delivery service. Specifically, the proposed STUDIO Software performs the following functions: - Data Upload: the SweetSpot Fetch Utility application will be used to access data from ● a Receiver, using either Mac or PC operating systems; - Data Analysis: certain SweetSpot Platform functions will be used to validate. ● aggregate, and analyze (e.g., correlate) CGM data, and to create charts and reports that mimic the current STUDIO Pattern and Glucose Strips charts and reports; - . Reports: The current STUDIO Pattern charts will be displayed on the user's computer screen, and both the Pattern and Glucose Strip charts can be saved to the user's computer in PDF format. Both reports may be printed by the user as a PDF document. The STUDIO Software uses only retrospective data stored on the G4 PLATINUM device to create statistical reports, and does not make treatment recommendations.
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