The following data is part of a premarket notification filed by Dexcom, Inc. with the FDA for Dexcom G7 Continuous Glucose Monitoring System.
| Device ID | K213919 |
| 510k Number | K213919 |
| Device Name: | Dexcom G7 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 |
| Correspondent | Holly Drake Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121 |
| Product Code | QBJ |
| CFR Regulation Number | 862.1355 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386270003416 | K213919 | 000 |
| 00386270003430 | K213919 | 000 |
| 00386270003423 | K213919 | 000 |
| 00386270002815 | K213919 | 000 |
| 00386270003676 | K213919 | 000 |
| 00386270003591 | K213919 | 000 |
| 00386270003621 | K213919 | 000 |
| 00386270003614 | K213919 | 000 |
| 00386270003478 | K213919 | 000 |
| 00386270004017 | K213919 | 000 |
| 00386270003386 | K213919 | 000 |
| 00386270001863 | K213919 | 000 |
| 00386270003294 | K213919 | 000 |
| 00386270002839 | K213919 | 000 |
| 00386270002822 | K213919 | 000 |
| 00386270002525 | K213919 | 000 |
| 00386270002518 | K213919 | 000 |
| 00386270002198 | K213919 | 000 |
| 00386270002808 | K213919 | 000 |
| 00386270002174 | K213919 | 000 |
| 00386270001870 | K213919 | 000 |
| 00386270000378 | K213919 | 000 |