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510(k) Data Aggregation

    K Number
    K181998
    Device Name
    CardioBand ECG Event Recorder
    Manufacturer
    Samsung Strategy and Innovation Center (SSIC)
    Date Cleared
    2018-11-15

    (112 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Samsung Strategy and Innovation Center (SSIC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioBand Event Recorder is indicated for use by adult patients, when prescribed by a physician, to record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation.
    Device Description
    The CardioBand Event Recorder is intended to be used by a single patient to record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation. The system consists of three components: a wrist-worn CardioBand, a smart-phone application, and a secure cloud. The CardioBand records ECG signals from the patient and sends them to the smart-phone application. The smart-phone application then sends the data to the cloud, where it can be accessed by qualified healthcare providers.
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