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Oxygen Deficiency clinical trials

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NCT ID: NCT03128372 Completed - Oxygen Deficiency Clinical Trials

Validation of Next Generation Cerebral and Tissue Oximeter

Start date: May 22, 2017
Phase: N/A
Study type: Interventional

This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.

NCT ID: NCT03080688 Completed - Oxygen Deficiency Clinical Trials

Prizma Pulse Oximeter Evaluation

Start date: April 15, 2016
Phase: N/A
Study type: Observational

This study is intended to evaluate performance of the new design sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically: - SpO2 value range 70% to 100% - 10 or more subjects, at least 3 of dark pigmentation - At least 200 data points - Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters: - 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions: - 4.1. ACCURACY OF PULSE OXIMETERS - 4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS - ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2 - 201.12.1.101 SpO2 accuracy of pulse oximeter equipment - 201.12.1.101.2 Determination of SpO2 accuracy