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510(k) Data Aggregation

    K Number
    K250093
    Device Name
    Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
    Manufacturer
    Linshom Medical, Inc.
    Date Cleared
    2025-09-26

    (255 days)

    Product Code
    BZQ
    Regulation Number
    868.2375
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K250093,K240271
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K250093,K240271

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

    Linshom Continuous Predictive Respiratory Monitoring 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 a portable and reliable system for detection of spontaneous respiration. It's 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.

    AI/ML Overview

    N/A

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