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510(k) Data Aggregation

    K Number
    K173461
    Device Name
    ECG recorder and Arrhythmia Detector
    Date Cleared
    2018-08-03

    (269 days)

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

    Smart Solutions Technologies SL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nuubo System is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety. The Nuubo system continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo System detects arrhythmias at the end of the monitoring period upon download of the ECG data. The Nuubo System is Rx use device.
    Device Description
    The Nuubo System, developed by Smart Solutions Technologies (SST), is a wearable device designed for ambulatory recording electrocardiogram (ECG) up to 30 days. The system is composed of 3 main components: - Nuubo30 – The Nuubo30 wearable is a single patient textile like a chest-belt that contains 4 textile electrodes in the inner side that are used for sensing patient 's ECG. - NuuboREC - The Nuubo recorder is a small, lightweight device that records ECG continuously. The device records 2 Leads of ECG data up to 30 days. The device also records data from a 3-axis accelerometer located inside the device. - Nuubo Leonardo - The Leonardo Software is installed on a computer where the patient´s ECG data stored in the recorder will be downloaded for subsequent analysis and report.
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