QDL — Integrated Continuous Glucose Monitoring System For Professional Retrospective Use Class II
Classification Details
- Product Code
- QDL
- Device Class
- Class II
- Regulation Number
- 862.1355
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use 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 |
|---|---|---|---|
| K182405 | dexcom | Dexcom Pro Q Continuous Glucose Monitoring System | November 2, 2018 |