QJS

Interoperable Automated Glycemic Controller, Insulin Suspend

产品代码

QJS

器械名称

Interoperable Automated Glycemic Controller, Insulin Suspend

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 862.1356

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)

1 件

FDA 分类定义

An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

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）。