Cardiovascular devices; classification of electrocardiograph electrodes. Final rule
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Updated: May 30, 2026

Benefits of Cardiac Resynchronization Therapy in an Asynchronous Heart Failure Model Induced by Left Bundle Branch Ablation and Rapid Pacing
Published on: December 11, 2017
Abstract:
The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.
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