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    K Number
    K231979
    Device Name
    Mecun SpO2 sensor
    Manufacturer
    Shenzhen Mecun Medical Supply Co., Ltd.
    Date Cleared
    2024-08-16

    (408 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K060576,K201360
    Why did this record match?
    Device Name :

    Mecun SpO2 sensor

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Mecun SpO2 sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. The sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

    Device Description

    Mecun SpO2 Sensor consists of a connector, cable and patient sensor terminal. The optical components of sensor contain a LED emitter and a LED detector assembled into the non-woven housing. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.

    AI/ML Overview

    The provided document describes the Mecun SpO2 sensor and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Standard / Guidance)Reported Device Performance (Mecun SpO2 sensor)Comment
    ISO 80601-2-61: 2017 SpO2 Accuracy (70-80% SpO2)±3%Meets requirement. The predicate device's accuracy was ±3% for 70-100%, implying the subject device also meets this, specifically within this range.
    ISO 80601-2-61: 2017 SpO2 Accuracy (80-100% SpO2)±2%Meets requirement. Better accuracy in this range compared to the predicate device's ±3% for 70-100%, but still within acceptable limits as per ISO 80601-2-61 and FDA guidance.
    ISO 80601-2-61: 2017 SpO2 Accuracy (
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