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    K Number
    K251751

    Validate with FDA (Live)

    Device Name
    Spo2 Sensor CSS032D
    Manufacturer
    Shenzhen Ykd Technology Co., Ltd.
    Date Cleared
    2025-12-19

    (193 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    18 - 33
    Reference & Predicate Devices
    K202851
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    YKD SpO2 sensor (Models: CSS032D) is indicated for continuous non-invasive monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate (PR) in adult patients (>40kg) within medical institutions. It is for fingertip use only and prohibited in emergency medical transport, home care, long-term monitoring, mobile patients, motion, and low perfusion conditions.

    Device Description

    The SpO2 sensor consist of a probe attached to the patient's finger. The sensor shall be connected to its corresponding pulse oximeter monitor with a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

    As an accessory of the legally marketed oximeters or patient monitors in the United States, the proposed device SpO2 Sensor is intended for hospital use and continuous monitoring of functional arterial oxygen saturation and pulse rate.

    AI/ML Overview

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