Hospital Cardiac Telemetry
The hospital cardiac telemetry device (product code QYW) is a Class 2 Cardiovascular prescription device (regulation 870.1025) intended to continuously record, display, and/or analyze electrocardiograms of patients in healthcare facilities for detecting conditions requiring prompt intervention, including automated detection of life-threatening arrhythmias and alarm generation with remote access capability. Requiring 510(k) clearance, it is intended for patients at elevated risk of serious cardiovascular events requiring prompt intervention and is staffed by onsite qualified personnel. It is designated as life-sustaining and is not an implant.
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Basic Information
- Product Code
- QYW
- Device Class
- FDA class 2
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.