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pacer sensing analyzer psa 100
Oscor Medical
Summary: The Pacer Sensing Analyzer PSA 100 is a medical device used to assess pacemaker functionality. It is primarily used by cardiologists and electrophysiologists to ensure proper pacemaker operation.
FDA Clearance Information
Pathway 510K
Number K882327 ↗
Decision Date October 6, 1988
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Pacer Sensing Analyzer PSA 100 was cleared by the FDA through the 510(k) pathway on October 6, 1988. It is manufactured by Oscor Medical and classified as a Class 2 device.
What It Is
The Pacer Sensing Analyzer PSA 100 is a diagnostic tool used to evaluate the performance of pacemakers. It measures the electrical signals from the heart and the pacemaker, ensuring the device is functioning correctly. This analyzer is crucial for detecting any malfunctions or adjustments needed in pacemaker settings.
Clinical Applications
This device is commonly used in cardiology and electrophysiology settings, particularly during pacemaker implantation or follow-up appointments. It is essential for ensuring that pacemakers are correctly sensing and pacing the heart, which is vital for patients with arrhythmias or heart block. The device is used in hospitals and specialized cardiac clinics.
Indications for Use
The Pacer Sensing Analyzer PSA 100 is indicated for use in patients who have pacemakers. It helps clinicians verify that the pacemaker is working correctly and making necessary adjustments to optimize patient outcomes.
Practical Considerations
The device is compatible with most pacemaker models and typically requires standard leads for connection. Clinicians should be familiar with the specific pacemaker model being evaluated to ensure accurate readings and adjustments.
Frequently Asked Questions
What is the Pacer Sensing Analyzer PSA 100 used for?
It is used to assess and ensure the proper functioning of pacemakers by measuring electrical signals from the heart and the pacemaker.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with pacemakers to verify their functionality and make necessary adjustments.
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.