QLG

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

产品代码

QLG

器械名称

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

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)

9 件

FDA 分类定义

An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.

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）。