QII

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

产品代码

QII

器械名称

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

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

FDA 历史累计 510(k)

1 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 for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

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）。