Product Classification

• Device: hospital cardiac telemetry
• Regulation Description: Arrhythmia detector and alarm (including ST-segment measurement and alarm).
• 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.
• Physical State: Battery-operated, Portable or body worn, Wet and/or dry electrodes, Wireless transmissions
• Technical Method: Records electrocardiogram through electrodes on a portable or body worn device and allow remote display of the electrocardiogram. Continuously and automatically analyzes the ECG and provides notifications and/or alarm generation.
• Target Area: Body
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: QYW
• Premarket Review: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.1025
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Third Party Review

Not Third Party Eligible