The following data is part of a premarket notification filed by Dexcom, Inc. with the FDA for Dexcom G6 Continuous Glucose Monitoring (cgm) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (cgm) System, Dexcom G6 Professional Continuous Glucose Monitoring (cgm) System.
| Device ID | K221259 |
| 510k Number | K221259 |
| Device Name: | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System |
| Classification | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Applicant | Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121 |
| Contact | Rachel Ellena |
| Correspondent | Rachel Ellena Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121 |
| Product Code | QBJ |
| Subsequent Product Code | QDK |
| Subsequent Product Code | QII |
| CFR Regulation Number | 862.1355 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-07-29 |