Clinical Interpretation of Peripheral Pulse Oximeters Labeled “Not for Medical Use”

1Department of Anesthesiology, Uniformed Services University of the Health Sciences, Bethesda, Maryland

2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland

2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland

2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland

2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland

3Center for Device Evaluation and Rehabilitation Health, Anesthesia Devices Branch, Food and Drug Administration, Silver Spring, Maryland

4Fischell Department of Bioengineering and Director of Regulatory Science Initiative, University of Maryland, College Park, Maryland

5FDA Center of Excellence in Regulatory Science, College Park, Maryland