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510(k) Data Aggregation

    K Number
    K181006
    Device Name
    BB-613 Watch Oximeter
    Manufacturer
    Bio-Beat Technologies Ltd.
    Date Cleared
    2018-09-21

    (158 days)

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

    Bio-Beat Technologies Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BB-613 Watch Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.
    Device Description
    The BB-613 device is a wrist-worn device consisting of a light source (LEDs) and sensor array on the backside of the device, with a user interface on the front side of the device. The LEDs transmit light into the subject's skin at their wrist, and part of this light is reflected from the tissue and detected by a photo-diode. The integrated display is used to display the blood saturation and pulse rate results. It also displays symbols that show if there was no signal or a weak signal. The device is powered by a rechargeable battery.
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