QDL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Medical specialty
- Clinical Chemistry
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Dexcom Pro Q Continuous Glucose Monitoring System (K182405) | Dexcom, Inc. | 2018-11-02 |
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