title: Medical devices; neurological devices; classification of the Near Infrared Brain Hematoma Detector. Final rule.
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.
mesh_terms: D002543:Cerebral Hemorrhage / Q000175:diagnosis*; D019719:Diagnostic Equipment / Q000145:classification*; D004869:Equipment Safety; D006406:Hematoma / Q000175:diagnosis*; D006801:Humans; D007259:Infrared Rays; D011356:Product Labeling / Q000331:legislation & jurisprudence; D019265:Spectroscopy, Near-Infrared / Q000145:classification* / Q000295:instrumentation / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration