BEUDAMED
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    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

    FDA Enforcement
    Class II ·Completed·CardioTek BV·July 12, 2017

    CardioTek EP-TRACER Software V2.x.

    FDA Enforcement
    Class II ·Completed·CardioTek BV·June 29, 2022