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.
Regulation Number: 21 CFR 878.2375
Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZQ Dated: September 11, 2024
FDA Clearance Documentation (pdf)
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