Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1610](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1610) → GXS — Monitor, Alpha

# GXS · Monitor, Alpha

_Neurology · 21 CFR 882.1610 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXS

## Overview

- **Product Code:** GXS
- **Device Name:** Monitor, Alpha
- **Regulation:** [21 CFR 882.1610](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1610)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **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._

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXS](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXS)

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