Product code QYW

Device name

Hospital Cardiac Telemetry

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1025

Review panel

CV

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset