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510(k) Data Aggregation

    K Number
    K212425
    Device Name
    MicroTrend System
    Date Cleared
    2024-11-07

    (1191 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ExoStat Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MicroTrend is indicated for monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic monitored parameters. This single-use device is indicated for use by qualified medical personnel to assess a patient's peripheral circulation status. The MicroTrend Monitor provides trending information on tissue POMCO2 readings measured by the disposable sensor every two minutes over a maximum of a continuous 4-hour monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.
    Device Description
    The MicroTrend System provides a method of assessing the partial pressure of carbon dioxide (PCO2) in the oral mucosa (POMCO2). The MicroTrend System is a device composed of a Monitor, disposable POMCO2 Sensor, and associated connectors. It is designed to be easy to use with minimum training. A single-use disposable POMCO2 sensor is calibrated and then secured against the inside of the patient's cheek. Once the sensor initiates monitoring, the value of POMCO2 is reported on the MicroTrend Monitor instrument display. The MicroTrend Monitor provides trending information on tissue PCO2 readings measured by the disposable sensor every two minutes over a maximum of a 4-hour continuous monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary. The MicroTrend System is intended for use as an adjunct to other standard hemodynamic monitored parameters to help interpret the patient condition, treatment, and action by qualified medical professionals.
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