The following data is part of a De Novo classification by Dexcom, Inc. with the FDA for Dexcom Share Direct Secondary Displays.
| DeNovo ID | DEN140038 |
| Device Name: | Dexcom Share Direct Secondary Displays |
| Classification | Continuous Glucose Monitor Secondary Display |
| Applicant | DEXCOM, INC. 6340 Sequence Drive San Diego, CA 92121 |
| Contact | Andrew K Balo |
| Product Code | PJT |
| CFR Regulation Number | 862.1350 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Clinical Chemistry |
| Classification Advisory | Clinical Chemistry |
| Type | Direct |
| Date Received | 2014-12-15 |
| Decision Date | 2015-01-23 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386270001917 | DEN140038 | 000 |
| 00386270001931 | DEN140038 | 000 |