FDA finalizes class II status for hyperoxia monitoring device adjunct to pulse oximetry
The FDA issued a final order on October 6, 2026, classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II with special controls. The order, effective October 6, 2026, codifies the classification that was first applied on October 12, 2023.
Primary source
Federal Register rule, October 6, 2026
Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry
Read the source: Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry federalregister.gov
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