Trials / Completed
CompletedNCT05674136
Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to compare the equivalence of the Masimo INVSENSOR00061 to RD SET Neo for SpO2 and performance of PR and RRp as the subjects undergo a controlled desaturation protocol. This type of study design is required to evaluate the performance of pulse oximeters based upon the ISO 80601-2-61 standard which is also adopted and referenced by the FDA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | INVSENSOR00061 | Noninvasive pulse oximeter sensor |
Timeline
- Start date
- 2022-11-18
- Primary completion
- 2022-12-07
- Completion
- 2022-12-07
- First posted
- 2023-01-06
- Last updated
- 2024-06-13
- Results posted
- 2024-06-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05674136. Inclusion in this directory is not an endorsement.