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510(k) Data Aggregation

    K Number
    K140847
    Device Name
    CARDIOSPY ECG HOLTER SYSTEMS
    Manufacturer
    LABTECH KFT.
    Date Cleared
    2014-12-05

    (246 days)

    Product Code
    MLO
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    LABTECH KFT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis. The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years): - · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia. - · Evaluation of patients for ST segment changes - Evaluation of patients with pacemakers - · Reporting of time domain heart rate variability - · Evaluation of a patient's response after resuming occupational activities (e.g., after MI. or cardiac surgery.) - · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients - Clinical and epidemiological research studies
    Device Description
    The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for blue tooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Exportavailable. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality.
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