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510(k) Data Aggregation

    K Number
    K240271
    Device Name
    Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
    Manufacturer
    Linshom Medical Inc.
    Date Cleared
    2024-09-11

    (224 days)

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

    Linshom Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Linshom Continuous Predictive Respiratory Monitor System (CPRMS) 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. The CPRMS 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. CPRMS measurements are used as an adjunct to other clinical information sources.
    Device Description
    The Linshom CPRMS (Continuous Predictive Respiratory Monitoring System) is portable, reliable and an inexpensive system for precise detection of spontaneous respiration. It is non-invasive and is not corrupted by motion artifacts. The system autonomously adapts to the local thermal environment to deliver a usable signal without complicated hardware and firmware processing.
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