QII — Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use Class II
FDA product code QII covers "Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use", a Class II medical device regulated under 21 CFR 862.1355. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QII
- Device Class
- Class II
- Regulation Number
- 862.1355
- Submission Type
- 510(k)
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191833 | Dexcom | Dexcom G6 Pro Continuous Glucose Monitoring System | Oct 7, 2019 |