= Pulse Oximeters: Premarket Notification Submissions by the FDA
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Primary source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-drug
Verified locator: FDA technical guidance issued 4 March 2013. Full published title includes `Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff`. Clinical Performance, SpO2 Accuracy, recommends comparing paired readings to simultaneous co-oximetry of arterial samples under controlled inspired-oxygen mixtures and reporting root mean square difference. Source is cited for technical validation methodology, not asserted to be the latest regulatory policy.
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