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susi ii pacemaker surveillance monitor
Ela Medical
Summary: The Susi II Pacemaker Surveillance Monitor is a device used to monitor patients with pacemakers. It is primarily used by cardiologists and electrophysiologists to ensure proper pacemaker function and patient safety.
FDA Clearance Information
Pathway 510K
Number K792602 ↗
Decision Date March 25, 1980
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Susi II Pacemaker Surveillance Monitor was cleared through the FDA 510(k) pathway on March 25, 1980. It is manufactured by Ela Medical and is classified as a Class 2 device under product code DTC.
What It Is
The Susi II Pacemaker Surveillance Monitor is a medical device designed to continuously monitor the function of implanted pacemakers. It works by receiving and analyzing signals from the pacemaker, ensuring it is operating correctly and alerting clinicians to any irregularities. This device is crucial for maintaining the safety and efficacy of pacemaker therapy in patients with cardiac arrhythmias.
Clinical Applications
This device is commonly used in cardiology and electrophysiology settings, particularly in outpatient clinics and hospitals. It is essential for patients who have undergone pacemaker implantation, allowing for ongoing monitoring and timely intervention if issues arise. The monitor is suitable for adult and elderly patients with conditions such as bradycardia or heart block, who require pacemaker support.
Indications for Use
The Susi II Pacemaker Surveillance Monitor is indicated for patients with implanted pacemakers. It is used to ensure the pacemaker is functioning correctly and to detect any malfunctions or irregularities that could affect patient health.
Practical Considerations
The device is typically compatible with a range of pacemaker models. Clinicians should ensure that the monitor is correctly calibrated and positioned to receive accurate data. Regular checks and maintenance are recommended to ensure optimal performance.
Frequently Asked Questions
What is the Susi II Pacemaker Surveillance Monitor used for?
It is used to monitor the function of implanted pacemakers, ensuring they operate correctly and safely.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings to manage patients with pacemakers.
What are the FDA-cleared indications?
The device is indicated for monitoring patients with implanted pacemakers to ensure proper function and detect any issues.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.