FDA Product Code QYW

Hospital Cardiac Telemetry

米国回収

0 件

510(k)

2 件

PMA

0 件

不具合報告

0 件

分類情報

デバイス名	Hospital Cardiac Telemetry
デバイスクラス	クラス II
21 CFR 規制番号	870.1025
審査区分	510(k)（市販前届出）
医療専門分野	循環器
定義（原文）	Devices are intended to continuously record, display, and/or analyze electrocardiograms of patients in in a healthcare facility for detecting conditions that may require prompt intervention. They may include automatic detection and recording of cardiac electrical activity, automated detection of life-threatening arrhythmias or other relevant conditions, and/or alarm generation. Devices may allow remote access and display of electrocardiograms acquired. Devices are intended for patients who require continuous monitoring in hospitals or healthcare facilities, with onsite medical review by qualified personnel at the central monitoring/analysis station followed by immediate notification of onsite qualified medical responders. Devices may be used for patients at elevated risk of serious cardiovascular events that would require prompt intervention. Devices are intended for prescription use only.
フラグ	生命維持機器

出典: openFDA（U.S. FDA）のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。

取得日: 2026.08.18

各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は米国FDA情報の概要を参照してください。