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510(k) Data Aggregation

    K Number
    K183710
    Device Name
    Vivio System
    Manufacturer
    Avicena LLC
    Date Cleared
    2019-10-04

    (277 days)

    Product Code
    DQD, DSK
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Avicena LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vivio System is indicated for low frequency (<200 Hz) or Bell Mode operation to acquire and transmit heart sound data to the tablet/UI (with Avicena App) for calculation of heart rate and display and playback of heart sounds (audio and visual). The Vivio System is intended to be used as part of a physical assessment of a patient by healthcare professionals for diagnostic decision support. It may be used for the detection and amplification of sounds from the heart and arteries with the use of selective frequencies. It can be used on any person undergoing a physical assessment.
    Device Description
    The Vivio Unit is an electronic stethoscope containing a membrane, placed on the skin over the carotid artery, that is displaced due to vibrations produced by the arterial pulse waveform and heart sounds associated with the aortic valve opening and closing. An infrared light photo reflector transmits and detects light to/from the membrane and outputs a current relative to the detected light (or membrane movement). Sensor electronics inside the Vivio Unit generate a current to operate the sensor, read the current produced by the sensor and output a voltage relative to the current. Filter electronics condition the sensor signal, process the data and communicate the data to the tablet with the Avicena App. The Vivio Unit is powered by an internal, rechargeable battery.
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