QDK

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

产品代码

QDK

器械名称

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

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

FDA 分类定义

An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

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）。