PZE

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

产品代码

PZE

器械名称

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

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 subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and 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）。