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510(k) Data Aggregation

    K Number
    K190734
    Device Name
    Linshom Respiratory Monitoring Device (LRMD)
    Manufacturer
    Linshom Management LLC
    Date Cleared
    2020-01-30

    (315 days)

    Product Code
    BZQ
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    Linshom Management LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Linshom Respiratory Monitoring Device (LRMD) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult (at least 22 years of age) patients. LRMD is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume. LRMD measurements are used as an adjunct to other clinical information sources.
    Device Description
    The Linshom Respiratory Monitoring Device (LRMD) is a medical device designed to monitor a patient's respiratory rate, tidal volume trend and seconds since last breath within a healthcare setting. The LRMD is a thermistor based respiratory monitor which includes the Thermistor Sensor Assembly (TSA), Integrated Linshom Module (ILM) Core, the power supply and software.
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