Product code QYW— Cardiovascular
HEARTRAC ECG MONITORING SYSTEM
- Classification name
- Hospital Cardiac Telemetry
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QYW
FDA has cleared devices under product code QYW between 1995 and 2014, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2014
- 1995
Top applicants under product code QYW
Recent clearances under product code QYW
Data sourced from openFDA. This site is unofficial and independent of the FDA.