The following data is part of a premarket notification filed by Dexcom, Inc. with the FDA for Dexcom G6 Continuous Glucose Monitoring (cgm) System.
| Device ID | K201328 |
| 510k Number | K201328 |
| Device Name: | Dexcom G6 Continuous Glucose Monitoring (CGM) System |
| Classification | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Applicant | Dexcom, Inc. 6310 Sequence Dr. San Diego, CA 92121 |
| Contact | Maryam Amini |
| Correspondent | Maryam Amini Dexcom, Inc. 6310 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 | 2020-05-19 |
| Decision Date | 2021-07-15 |