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510(k) Data Aggregation

    K Number
    K111888
    Manufacturer
    Date Cleared
    2011-09-23

    (84 days)

    Product Code
    Regulation Number
    870.2700
    Reference & Predicate Devices
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    Device Name :

    MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS

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

    The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoqlobin (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 hospitals, hospital-type facilities, mobile, and home environments.

    Device Description

    The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are pulse oximetry sensors. They measure tissue oxygenation non-invasively through infrared emitters and detectors. They are fully compatible for use with Masimo SET and Masimo Rainbow SET instruments.

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