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Prizma Pulse Oximeter Evaluation

G Medical Innovations Ltd. · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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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
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