Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1430](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1430) → GWR — Generator, Electroencephalograph Test Signal

# GWR · Generator, Electroencephalograph Test Signal

_Neurology · 21 CFR 882.1430 · Class 1_

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

## Overview

- **Product Code:** GWR
- **Device Name:** Generator, Electroencephalograph Test Signal
- **Regulation:** [21 CFR 882.1430](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1430)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

## 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/GWR](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWR)

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