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Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)

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Contents

clinicaltrials.gov/study/NCT01319396
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT013193960
Trial Recruitment Size
240
Trial Sponsor
ResMed
ResMed
0
Clinical Trial Start Date
2010
0
Primary Completion Date
2010
0
Study Completion Date
2011
0
Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Case-Only0
Observational Study Perspective
Cross-Sectional0
Participating Facility
ResMed
ResMed
0
Official Name
Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)0
Last Updated
April 1, 2021
0
Study summary

The purpose of this study is to compare the accuracy of the BiancaMed BM07 breathing frequency indicator device with the respiration rate measured by a SomnoScreen RC Easy device on 20+ human volunteers. This is being carried out in support of a 510(k) submission.

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