Product code QII— Clinical Chemistry
Dexcom G6 Pro Continuous Glucose Monitoring System
- Classification name
- Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QII
FDA has cleared device under product code QII, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QII
Recent clearances under product code QII
Data sourced from openFDA. This site is unofficial and independent of the FDA.