 |
Code of Federal Regulations (Last Updated: April 5, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 882 - Neurological Devices |
|
Subpart B - Neurological Diagnostic Devices |
§ 882.1610 - Alpha monitor.
Latest version.
-
§ 882.1610 Alpha monitor.
(a) Identification. An alpha monitor is a device with electrodes that are placed on a patient's scalp to monitor that portion of the electroencephalogram which is referred to as the alpha wave.
(b) Classification. Class II (performance standards).