OYC

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

产品代码

OYC

器械名称

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

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

The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.

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）。