SFI

Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System

产品代码: SFI
器械名称: Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
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 device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA.

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）。

FDA 官方分类页： SFI

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。