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Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study

NCT03439306 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2018-02-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the oxygen saturation accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions

Conditions

Interventions

DEVICE

Pulse Oximeter

The Pulse Oximeter are placed on the left and right Index fingers of each subject of the healthy adult volunteer group to evaluate the SpO2 accuracy performance.

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Belun Technology Company Limited

    lead OTHER

Principal Investigators

  • Arthur Ruiz Cabrera, M.D. · Clinimark, LLC

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2017-03-17
Completion
2017-03-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439306 on ClinicalTrials.gov