PQF

Sensor, Glucose, Invasive, Non-Adjunctive

产品代码

PQF

器械名称

Sensor, Glucose, Invasive, Non-Adjunctive

管理类别

第 3 类（Class III）

FDA 专业组

Unknown

上市路径

需 PMA 上市前批准

FDA 分类定义

A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

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）。