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510(k) Data Aggregation

    K Number
    K083622

    Validate with FDA (Live)

    Device Name
    LNCS OXIMETRY SENSORS
    Manufacturer
    MASIMO CORPORATION
    Date Cleared
    2009-04-02

    (115 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K041815,K051212,K060143
    Predicate For
    K110723
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LNCS Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

    Device Description

    The LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximetry Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.

    There is no change in the sensor design or performance. The only change is that the sensors are to be subjected to ethylene oxide (EO) sterilization and are to be supplied as sterile sensors by Masimo.

    AI/ML Overview

    N/A

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