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external pacemaker analyzer model pmt 100
North American Technical Services
Summary: The external pacemaker analyzer PMT 100 is a diagnostic tool used to evaluate the function of external pacemakers. It is primarily used by cardiologists and electrophysiologists in clinical settings.
FDA Clearance Information
Pathway 510K
Number K961582 ↗
Decision Date November 8, 1996
Product Code DTC
Device Class Class 2
Evidence 0 studies
The external pacemaker analyzer PMT 100 was cleared through the FDA 510(k) pathway on November 8, 1996. It is manufactured by North American Technical Services and classified as a Class 2 medical device.
What It Is
The external pacemaker analyzer PMT 100 is a device designed to test and analyze the performance of external pacemakers. It measures parameters such as pacing rate, output, and sensitivity, ensuring the pacemaker is functioning correctly. This device is essential for verifying the accuracy and reliability of pacemakers before and during patient use.
Clinical Applications
This device is commonly used in cardiology and electrophysiology departments to ensure the proper functioning of external pacemakers. It is used in hospital settings, particularly in cardiac care units, where patients may require temporary pacing support. The analyzer is crucial for patients with arrhythmias or those undergoing cardiac surgery who need temporary pacing.
Indications for Use
The external pacemaker analyzer is indicated for use in testing and verifying the performance of external pacemakers. It is intended for patients who require temporary cardiac pacing, ensuring the pacemaker delivers the correct pacing parameters.
Practical Considerations
The device is typically compatible with a range of external pacemakers. Clinicians should ensure proper connection and calibration before use. Familiarity with the device's interface and measurement capabilities is important for accurate analysis.
Frequently Asked Questions
What is the external pacemaker analyzer PMT 100 used for?
It is used to test and verify the performance of external pacemakers, ensuring they function correctly.
What specialties typically use this device?
Cardiology and electrophysiology specialists typically use this device in clinical and hospital settings.
What are the FDA-cleared indications?
The device is indicated for testing and verifying the performance of external pacemakers in patients requiring temporary cardiac pacing.
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.