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510(k) Data Aggregation

    K Number
    K162956
    Device Name
    NOWCARDIO SYSTEM
    Manufacturer
    CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC.
    Date Cleared
    2017-09-22

    (333 days)

    Product Code
    QYX, DSI, MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Now Cardio™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as: - · Atrial Fibrillation - · Bradycardia - Tachycardia - · Pause It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Now Cardio™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting. Now Cardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.
    Device Description
    The NowCardio™ System is a wearable, wireless arrhythmia detection system that provides continuous cardiac monitoring functionality for an extended period of up to 32 days. The NowCardio System is prescribed by healthcare providers to monitor, record, and report on a patient's electrocardiographic (ECG) data. The NowCardio™ system consists of: (1) a wearable electronic component that collects and monitors a patient's ECG data referred to as a NowCardio™ Sensor; (2) a custom cradle, referred to as the NowCardio™ Cradle, that is used to configure/charge the NowCardio™ Sensor in addition to providing ECG data download capability; and (3) a Remote Data Management System (RDMS) which is a remote server with software that will allow qualified healthcare providers to receive, analyze, interpret, and report on the results of the ECG test. The NowCardio™ System can be equipped with an optional Transmitter. The NowCardio™ Transmitter is used to transmit data acquired from the NowCardio™ Sensor to the RDMS as cardiac events are detected or patient triggered.
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