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510(k) Data Aggregation

    K Number
    K981655
    Date Cleared
    1999-12-03

    (571 days)

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

    SPACELABS MEDICAL DISPOSABLE SP02 SENSOR

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

    Physiological purpose. An accessory to an SpO2 monitoring system for use in noninvasive, continuous monitoring of oxygen saturation for the detection of desaturation due to abnormal pulmonary/circulatory function in adult, pediatric or infant population by the standard photoelectric pulse of oximetric technique.

    Device Description

    As an accessory to a pulse oximeter monitoring module in a Spacelabs Medical Patient Care Information System (PCIS), a Spacelabs Medical Disposable SpO2 sensor provides the means to noninvasively acquire SpO2 signals from the patient's fingertip or for the continuous monitoring of pulse saturation signals.

    The SpO2 sensor converts optical signals into electrical signals from common monitoring sites. The acquired signals are transferred via an adapter cable to a pulse oximeter monitor for subsequent display, review, and editing by the care provider.

    Sensors are available for specific monitoring sites, including the fingertip and foot, and are sized to meet various adult, pediatric and infant patient needs.

    AI/ML Overview

    I'm sorry, but relevant information is not found in the provided text to generate a response. The document mostly focuses on the regulatory aspects of the device, such as its classification, predicate devices, and FDA approval, rather than detailed performance study data.

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