 Pulse Oximeters: Premarket Notification Submissions by the FDA

Primary source: 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.