Medical devices; neurological devices; classification of the Near Infrared Brain Hematoma Detector. Final rule
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A Bedside, Single Burr Hole Approach to Multimodality Monitoring in Severe Brain Injury
Published on: March 26, 2019
Federal Register
|April 7, 2012
Abstract:
The Food and Drug Administration (FDA) is classifying the Near Infrared (NIR) Brain Hematoma Detector into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

