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510(k) Data Aggregation

    K Number
    K193296
    Device Name
    eCordum Cardiac Monitor (eCordum CM)
    Manufacturer
    eCordum, Inc.
    Date Cleared
    2020-10-30

    (338 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    eCordum, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eCordum™ Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.
    Device Description
    The eCordum™ Cardiac Monitor (eCordum™ CM) is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and it is not intended for pediatric use. The eCordum™ CM device is powered by a replaceable battery and has two interchangeable attachable covers with respective ECG electrodes for long-term ECG recording. The Wearable Unit for long-term recording is used with two standard disposable Off-The-Shelf (OTS) ECG electrodes. For long term recording ECG data is obtained by attaching the device to user's chest using OTS ECG electrodes. Long-term recordings provide a single channel ECG signal. During recording the device collects and encrypts ECG data in the storage media for unidirectional transmission to a Bluetooth enabled device.
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