đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For evaluating and testing the function of pacemakers.
- For measuring pacemaker output and sensing-related parameters, including pulse amplitude, pulse width, and sensing thresholds.
Clinical Applications
- Testing pacemaker performance in patients with implanted pacemakers.
- Evaluating pacing output and sensing thresholds during pacemaker implantation.
- Checking pacemaker function during follow-up examinations.
- Providing measurements that help clinicians assess or adjust pacemaker settings.
Practical Considerations
- The analyzer should be used by trained cardiology or electrophysiology personnel familiar with the pacemaker being tested.
- Compatibility and testing capability should be confirmed for the specific pacemaker model and pacing system before use.
- The device requires appropriate calibration, maintenance, and functional checks to support accurate measurements.
- The analyzer is an external testing instrument and is not implanted in the patient.
- MRI safety depends on the analyzer's presence in or near the MRI environment; the device should not be taken into an MRI area unless its labeling confirms that use is permitted.
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.