Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector
Information
Type
Rule
Regulated products
Medical Devices
Published
March 23, 2012
Last updated
March 23, 2012
Description
Document number 2012-6975. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)