The following data is part of a premarket notification filed by Dexcom, Inc. with the FDA for Dexcom G6 Pro Continuous Glucose Monitoring System.
| Device ID | K191833 |
| 510k Number | K191833 |
| Device Name: | Dexcom G6 Pro Continuous Glucose Monitoring System |
| Classification | Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use |
| Applicant | Dexcom, Inc. 6310 Sequence Dr. San Diego, CA 92121 |
| Contact | Jacob Nardone |
| Correspondent | Jacob Nardone Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121 |
| Product Code | QII |
| CFR Regulation Number | 862.1355 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-09 |
| Decision Date | 2019-10-07 |
| Summary: | summary |