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510(k) Data Aggregation

    K Number
    K213933
    Device Name
    Percent Oxygen Sensors
    Manufacturer
    CareOx, LLC
    Date Cleared
    2022-08-19

    (246 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    CareOx, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Percent Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.
    Device Description
    The subject device is a family of Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices. The oxygen sensors are all electrochemical galvanic type devices. The difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time. The family of oxygen sensors concept extends to OEM manufacturers of anesthesia and respiratory therapy equipment. Again, the difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time in order for the OEM to exercise a degree of control over the recurring replacement of oxygen sensors.
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