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external pacemaker analyzer model pma-1
Bio-Tek Instruments
Summary: The external pacemaker analyzer model PMA-1 by Bio-Tek Instruments is a device used to test and analyze the function of external pacemakers. It is primarily used by cardiologists and biomedical technicians in clinical settings.
FDA Clearance Information
Pathway 510K
Number K903966 ↗
Decision Date June 19, 1991
Product Code DTC
Device Class Class 2
Evidence 0 studies
The external pacemaker analyzer model PMA-1 was cleared through the FDA 510(k) pathway on June 19, 1991. Manufactured by Bio-Tek Instruments, it is classified as a Class 2 medical device under product code DTC.
What It Is
The external pacemaker analyzer model PMA-1 is a diagnostic tool designed to evaluate the performance and functionality of external pacemakers. It measures parameters such as pulse rate, amplitude, and duration to ensure the pacemaker is functioning correctly. This device is essential for verifying the operational status of pacemakers before they are used on patients, ensuring safety and efficacy.
Clinical Applications
This device is commonly used in cardiology departments and by biomedical technicians in hospitals and clinics. It is employed during routine maintenance checks of pacemakers and in troubleshooting scenarios where pacemaker malfunction is suspected. The analyzer is crucial for ensuring that pacemakers deliver the correct pacing to patients with cardiac arrhythmias or heart block.
Indications for Use
The FDA indications for the external pacemaker analyzer model PMA-1 involve its use in testing and verifying the performance of external pacemakers. It is intended for use in settings where pacemakers are routinely checked, such as hospitals and cardiac care units.
Practical Considerations
The PMA-1 is compatible with a variety of external pacemaker models and typically requires standard electrical connections. Users should be familiar with pacemaker technology and have training in biomedical equipment operation to effectively use the device.
Frequently Asked Questions
What is the external pacemaker analyzer model PMA-1 used for?
It is used to test and analyze the function of external pacemakers, ensuring they operate correctly before patient use.
What specialties typically use this device?
Cardiologists and biomedical technicians in hospitals and clinics typically use this device.
What are the FDA-cleared indications?
The device is indicated for testing and verifying the performance of external pacemakers in clinical settings.
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.