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model 674 pacer analyzer
Del Mar Avionics
Summary: The Model 674 Pacer Analyzer is a medical device used to test and analyze pacemakers. It is primarily used by cardiologists and electrophysiologists in clinical settings to ensure pacemaker functionality and safety.
FDA Clearance Information
Pathway 510K
Number K792074 ↗
Decision Date December 27, 1979
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Model 674 Pacer Analyzer by Del Mar Avionics was cleared through the FDA 510k pathway on December 27, 1979. It is classified as a Class 2 medical device under product code DTC.
What It Is
The Model 674 Pacer Analyzer is a diagnostic tool designed to evaluate the performance of pacemakers. It measures various parameters such as pulse amplitude, pulse width, and sensing thresholds. This device ensures that pacemakers are functioning correctly and safely, providing critical data to healthcare providers for patient management.
Clinical Applications
This device is commonly used in cardiology and electrophysiology departments, particularly during pacemaker implantation and follow-up visits. It is essential in hospital settings and specialized cardiac clinics where pacemaker patients are monitored. The analyzer assists in optimizing pacemaker settings for individual patient needs, ensuring effective pacing therapy.
Indications for Use
The FDA indications suggest that this device is intended for use in evaluating and testing pacemakers. It is suitable for patients with implanted pacemakers, allowing clinicians to verify device performance and adjust settings as needed.
Practical Considerations
The Model 674 Pacer Analyzer is compatible with most pacemaker models. Clinicians should be familiar with the specific pacemaker being tested to interpret results accurately. Regular calibration and maintenance of the analyzer are recommended to ensure precise measurements.
Frequently Asked Questions
What is the Model 674 Pacer Analyzer used for?
It is used to test and analyze the functionality of pacemakers, ensuring they operate correctly and safely.
What specialties typically use this device?
Cardiology and electrophysiology specialists commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for evaluating and testing pacemakers to ensure proper function and patient safety.
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.