21 CFR 882.1610 — Monitor, Alpha
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1610
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXS | Monitor, Alpha | 2 | 0 | 3rd Party |
