SIF

Software Device System For Estimation Of Cardiac Pressures

产品代码

SIF

器械名称

Software Device System For Estimation Of Cardiac Pressures

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.1150

FDA 专业组

Cardiovascular

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

This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure.

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）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2026-05-22。