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510(k) Data Aggregation

    K Number
    K161245
    Device Name
    EP-TRACER System
    Manufacturer
    CARDIO TEK, BV
    Date Cleared
    2016-08-05

    (94 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIO TEK, BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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.
    Device Description
    The EP-TRACER System is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is comprised of these major components, 1. EP-TRACER hardware – Amplifier/stimulator 2. EP-TRACER Software – Software pre-installed
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