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510(k) Data Aggregation

    K Number
    K232520
    Device Name
    Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
    Manufacturer
    Shenzhen Smallsignal Technology Co., Ltd.
    Date Cleared
    2024-11-21

    (461 days)

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

    Shenzhen Smallsignal Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environment. And it is not intended to be used under motion or low perfusion scenarios.
    Device Description
    The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpQ2), The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. Bluetooth function is available for Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20LB, Alpine20LB, Alpine20LBH, Alpine30LB and Alpine30LBH only.
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