Owlet Baby Care, Inc.
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
The objective of this study is to collect evidence to verify the accuracy of the Owlet OSS 3.0-M1 Sensor to measure SpO2 and pulse rate in children 19-60 months in a simulated use environment as compared to an FDA cleared reference pulse oximeter.
Inclusion Criteria: 1. Subject is between 19 months and ≤ 60 months of age. 2. Subject's current body weight is ≥ 6 lbs. 3. Subject/legal guardian is fluent in both written and spoken English. 4. Subject is willing and able to follow study requirements 5. Legal guardian has provided consent. Exclusion Criteria: 1. Subject has preexisting cardiovascular or respiratory disease or conditions. 2. Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements. 3. The device(s) are unable to fit proper…
Owlet OSS 3.0-M1 Sensor
Application and monitoring with an FDA cleared reference pulse oximeter
Arctuva estimate
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