View clinical trials related to Oxygen Deficiency.
Filter by:This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.
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