The following data is part of a De Novo classification by Dexcom, Inc. with the FDA for Dexcom G6 Continuous Glucose Monitoring System.
| DeNovo ID | DEN170088 |
| Device Name: | Dexcom G6 Continuous Glucose Monitoring System |
| Classification | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Applicant | Dexcom, Inc. 6340 Sequence Dr San Diego, CA 92121 |
| Contact | Neeta Sharma |
| Product Code | QBJ |
| CFR Regulation Number | 862.1355 [🔎] |
| 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 | 2017-12-08 |
| Decision Date | 2018-03-27 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386270000811 | DEN170088 | 000 |
| 00386270001061 | DEN170088 | 000 |
| 00386270001900 | DEN170088 | 000 |
| 00386270001627 | DEN170088 | 000 |
| 00386270000590 | DEN170088 | 000 |
| 00386270001931 | DEN170088 | 000 |
| 00386270001917 | DEN170088 | 000 |
| 80386270000251 | DEN170088 | 000 |
| 70386270000254 | DEN170088 | 000 |
| 00386270001092 | DEN170088 | 000 |
| 00386270001641 | DEN170088 | 000 |
| 00386270000804 | DEN170088 | 000 |
| 00386270000583 | DEN170088 | 000 |
| 00386270000385 | DEN170088 | 000 |
| 00386270000255 | DEN170088 | 000 |
| 10386270001037 | DEN170088 | 000 |
| 00386270001788 | DEN170088 | 000 |
| 00386270001771 | DEN170088 | 000 |
| 00386270001764 | DEN170088 | 000 |
| 60386270000257 | DEN170088 | 000 |