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510(k) Data Aggregation
K Number
K240271Device Name
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Manufacturer
Linshom Medical Inc.
Date Cleared
2024-09-11
(224 days)
Product Code
BZQ
Regulation Number
868.2375Why 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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