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Outpatient Cardiac Telemetry

FDA product code QYX · 19 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1025
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1998-11-13 – 2026-04-21

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.

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