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510(k) Data Aggregation

    K Number
    K190775
    Device Name
    The RHEA Vital Sign Vigilance System
    Date Cleared
    2019-12-19

    (268 days)

    Product Code
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Fiber Medical Technology Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RHEA Vital Sign Vigilance System is intended for continuous measurement of respiration rate and heart rate for adults (≤150kg), in an automatic contact-less manner, in hospital or clinic setting condition.
    Device Description
    The RHEA Vital Sign Vigilance System is designed for continuous and contact-less measurement of a patient's heart rate and respiratory rate. The system can also notify the user when the patient exits the bed. The system incorporates three main components: Bedside unit, Sensor unit (including fiber cable), and Data Export Software. The sensor detects movement vibrations from the patient's body and converts them into an optical signal. The bedside unit receives the optical signal from the sensor, calculates the heart rate and respiratory rate, displays the vital signs on the screen in real-time, and records and stores the patient data.
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