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510(k) Data Aggregation

    K Number
    K201887
    Device Name
    VS Newborn Heart Rate Monitor
    Date Cleared
    2021-07-23

    (380 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    SurePulse Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VS Newborn Heart Rate Monitor is indicated for the continuous monitoring of heart rate in neonatal patients. The device uses reflectance photoplethysmography to determine heart rate. The sensor is integrated into a cap placed on the head of the patient. The VS Newborn Heart Rate Monitor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
    Device Description
    The VS Newborn Heart Rate Monitor is a non-invasive device intended to continuously monitor heart rate (HR) in neonates immediately after delivery and in newborn intensive care units (NICU). The VS Newborn Heart Rate Monitor measures HR using reflectance photoplethysmography (PPG). The sensor is integrated into a single-use soft cap placed on the head of the newborn such that the sensor contacts the forehead of the newborn. The PPG signal and HR are displayed on the monitor. The VS Newborn Heart Rate Monitor is designed for use in hospitals.
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