DEN140016 is an FDA 510(k) submission for the STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE. This device is classified as a Continuous Glucose Monitor Retrospective Data Analysis Software (Class I - General Controls, product code PHV).
Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on August 19, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2120. Continuous Glucose Monitor Retrospective Data Analysis Software Is Intended To Analyze And Correlate Retrospective Data From A Continuous Glucose Monitoring Device..
| 510(k) Number | DEN140016 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 22, 2014 |
| Decision Date | August 19, 2014 |
| Days to Decision | 119 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | PHV — Continuous Glucose Monitor Retrospective Data Analysis Software |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2120 |
| Definition | Continuous Glucose Monitor Retrospective Data Analysis Software Is Intended To Analyze And Correlate Retrospective Data From A Continuous Glucose Monitoring Device. |