SFU
- 产品代码
- SFU
- 器械名称
- Glucose Range Monitoring System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.1359
- FDA 专业组
- Clinical Chemistry
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
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.
该代码近三年的 510(k)（1 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| DEN240080 | 2025-09-23 | Biolinq Incorporated | Biolinq Shine Autonomous Time-in-Range Microsensor | — |
FDA 官方分类页： SFU
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。