Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K180805
    Device Name
    Pure EP
    Date Cleared
    2018-08-08

    (133 days)

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

    BioSig Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PURE EP™ is a computerized system intended for acquiring, digitizing, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.
    Device Description
    PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC), which are connected over a high-speed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1