SAF

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

产品代码

SAF

器械名称

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 862.1355

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)

4 件

其中 Summary 已存档

2 份，可直接下载

FDA 历史累计 510(k)

4 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（4 件）

数据窗口为最近三年。最新一件：2026-05-21。

其中 2 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。