SBA

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

产品代码

SBA

器械名称

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 862.1357

FDA 专业组

Clinical Chemistry

上市路径

需提交 510(k) 上市前通告

标记

属植入器械

该代码近三年的 510(k)

2 件

其中 Summary 已存档

1 份，可直接下载

FDA 历史累计 510(k)

2 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) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.

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)（2 件）

数据窗口为最近三年。最新一件：2024-09-16。

其中 1 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。