SFU — Glucose Range Monitoring System Class II
Classification Details
- Product Code
- SFU
- Device Class
- Class II
- Regulation Number
- 862.1359
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently. GRM systems are intended to support general user awareness of glucose ranges related to glycemic control. Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240080 | biolinq incorporated | Biolinq Shine Autonomous Time-in-Range Microsensor | September 23, 2025 |