QYX

Outpatient Cardiac Telemetry

产品代码

QYX

器械名称

Outpatient Cardiac Telemetry

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.1025

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)

21 件

FDA 分类定义

Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.

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)（5 件）

数据窗口为最近三年。最新一件：2026-04-21。

其中 3 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。