Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation

摘要

The Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the monitor for opioid induced impairment of oxygenation. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiv