K191833 is an FDA 510(k) clearance for the Dexcom G6 Pro Continuous Glucose Monitoring System. This device is classified as a Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use (Class II - Special Controls, product code QII).
Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on October 7, 2019, 90 days after receiving the submission on July 9, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1355. An Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use Is A Continuous Glucose Recording Device Indicated For Use As Directed By A Physician Either For The Real-time Management Of Diabetes At Home Or For The Retrospective Discovery, Analysis, And Interpretation Of Glycemic Variability In Persons Age 2 And Older By Healthcare Professionals To Guide Appropriate Patient Management. The System Is Also Intended To Interface With Digitally Connected Devices..
| 510(k) Number | K191833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2019 |
| Decision Date | October 07, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QII — Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1355 |
| Definition | An Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use Is A Continuous Glucose Recording Device Indicated For Use As Directed By A Physician Either For The Real-time Management Of Diabetes At Home Or For The Retrospective Discovery, Analysis, And Interpretation Of Glycemic Variability In Persons Age 2 And Older By Healthcare Professionals To Guide Appropriate Patient Management. The System Is Also Intended To Interface With Digitally Connected Devices. |