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510(k) Data Aggregation
K Number
DEN140016Device Name
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
Manufacturer
DEXCOM, INC.
Date Cleared
2014-08-19
(119 days)
Product Code
PHV
Regulation Number
862.2120Why did this record match?
Product Code :
PHV
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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