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510(k) Data Aggregation

    K Number
    K201302
    Device Name
    LiveOne
    Date Cleared
    2022-05-04

    (719 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    LiveMetric (Medical) S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LiveOne is intended to be used in patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The LiveOne is intended to be used on subjects ≥ 27 years old and who have a palpable radial pulse. Software is used to provide data to qualified medical professionals for the purpose of assessing the patient's cardiac health via blood pressure readings in clinic setting by health care professional. LiveOne is intended only for measurement and display; it makes no diagnosis.
    Device Description
    The LiveOne is a non-invasive blood pressure monitor that utilizes a single patient use non-invasive pressure sensor placed on the wrist over the radial artery, and an electronic interface module. The device uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, and pulse rate and a pressure waveform. The device allows the healthcare provider to monitor blood pressure (based on visual waveform) in a clinical setting.
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