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Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Fever Clinical Trial

Official title:
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Clinical Trial Summary

This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.

Clinical Trial Description

Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344 and NCT05779397). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05787782
Study type Interventional
Source Masimo Corporation
Contact
Status Completed
Phase N/A
Start date February 23, 2023
Completion date March 2, 2023
View Details
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