DEN140038 is an FDA 510(k) submission for the Dexcom Share Direct Secondary Displays. This device is classified as a Continuous Glucose Monitor Secondary Display (Class II - Special Controls, product code PJT).
Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on January 23, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1350. The Purpose Of The Continuous Glucose Monitor Secondary Display Is To Notify Another Person, The Follower, Of The Patient's Continuous Glucose Monitoring System Sensor Glucose Information In Real Time. The Secondary Display Is Intended For Providing Secondary Notification Of A Continuous Glucose Monitoring System And Does Not Replace Primary Real Time Continuous Glucose Monitoring Or Standard Home Blood Glucose Monitoring.
| 510(k) Number | DEN140038 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 15, 2014 |
| Decision Date | January 23, 2015 |
| Days to Decision | 39 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | PJT — Continuous Glucose Monitor Secondary Display |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1350 |
| Definition | The Purpose Of The Continuous Glucose Monitor Secondary Display Is To Notify Another Person, The Follower, Of The Patient's Continuous Glucose Monitoring System Sensor Glucose Information In Real Time. The Secondary Display Is Intended For Providing Secondary Notification Of A Continuous Glucose Monitoring System And Does Not Replace Primary Real Time Continuous Glucose Monitoring Or Standard Home Blood Glucose Monitoring |