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510(k) Data Aggregation

    K Number
    K231531
    Device Name
    Pediarity™
    Manufacturer
    Date Cleared
    2023-12-21

    (209 days)

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

    Gabi SmartCare SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pediarity™ system is intended for use in the home setting and/or continuous recording of pulse rate (PR) and functional oxygen saturation of arterial hemoglobin (SpO2) of well-perfused infants and children in non-notion conditions. The Pediarity™ system is not a monitoring device and does not provide physiological alarms during use. Measurements are sent to a web server for remote review by a physician.
    Device Description
    The Pediarity™ system is a non-invasive, innovative, and advanced solution that allows to measure wirelessly several physiological parameters (SpO2, Pulse Rate) of infants and children up to 12 years old in non-motion conditions. The Pediarity™ system is composed of: - a) Gabi™ Band, a non-invasive, wearable, wireless measuring device positioned around the patient's upper arm. - b) Gabi™ Monitor, made of: - Gabi Monitor App: a mobile application dedicated to caregivers, allowing to o start and stop a recording of physiological parameters measured by the Gabi Band, displays measuring information and transfers collected data to the Gabi Cloud via Wi-Fi. - Gabi Monitor Tablet: a tablet provided to the caregiver inside the solution o package, on which the Gabi Monitor App is pre-installed. - c) A Gabi™ Cloud, an online service that stores and manages the collected data and shares them with Gabi Analytics. - d) Gabi™ Analytics, a web interface allowing the Healthcare Professionals (HCP) to access and review remotely the physiological parameters of the patient.
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