GXS · Monitor, Alpha
Neurology · 21 CFR 882.1610 · Class 2
Overview
| Product Code | GXS |
|---|---|
| Device Name | Monitor, Alpha |
| Regulation | 21 CFR 882.1610 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
