Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1420](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1420) → GWS — Analyzer, Spectrum, Electroencephalogram Signal

# GWS · Analyzer, Spectrum, Electroencephalogram Signal

_Neurology · 21 CFR 882.1420 · Class 1_

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

## Overview

- **Product Code:** GWS
- **Device Name:** Analyzer, Spectrum, Electroencephalogram Signal
- **Regulation:** [21 CFR 882.1420](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1420)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal.

## Classification Rationale

Class I (general controls).

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K974718](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K974718.md) | PERSYST PRISM | Persyst Development Corp. | Mar 9, 1998 | SESE |
| [K925735](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K925735.md) | EEG ANALYZER | Bio-Scan, Inc. | Dec 3, 1993 | SESE |
| [K912938](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K912938.md) | RHYTHM | Stellate Systems | Jul 30, 1991 | SESE |
| [K894629](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K894629.md) | NICOLET BEAM II SYSTEM | Nicolet Instrument Corp. | Mar 9, 1990 | SESE |
| [K871931](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K871931.md) | ISTAT SOFTWARE | Neuroscience, Inc. | Oct 13, 1987 | SESE |
| [K871480](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K871480.md) | STD-228  SPECTRAL TREND DISPLAY | Grass-Telefactor Product Group | May 1, 1987 | SESE |
| [K854662](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K854662.md) | OEE_7102 EEG/TREND MONITOR | Nihon Kohden America, Inc. | Aug 20, 1986 | SESE |
| [K860829](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K860829.md) | CNS 4/8 AND CT 48.1 SOFTWARE | Cns, Inc. | May 29, 1986 | SESE |
| [K854160](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K854160.md) | CNS-16 & LTM 1.0 SOFTWARE | Cns, Inc. | Jan 10, 1986 | SESE |
| [K850430](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K850430.md) | NEUROSCIENCE MAP-10 EEG | Neuroscience, Inc. | Jul 17, 1985 | SESE |
| [K844481](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K844481.md) | NEUROLAB II | Teca, Inc. | May 20, 1985 | SESE |
| [K844015](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K844015.md) | CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE | Cns, Inc. | Dec 17, 1984 | SESE |
| [K803233](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K803233.md) | MEUROMETRICS MONITOR | Dade Medical, Inc. | Jan 12, 1981 | SESE |
| [K800452](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K800452.md) | NEUROMETRICS MONITOR | Neurometrics | Apr 2, 1980 | SESE |
| [K800001](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWS/K800001.md) | MINI-CEARS COMPUTER (MODEL 1) | Bik Foundation, Inc. | Jan 31, 1980 | SESE |

## Top Applicants

- Cns, Inc. — 3 clearances
- Neuroscience, Inc. — 2 clearances
- Bik Foundation, Inc. — 1 clearance
- Bio-Scan, Inc. — 1 clearance
- Dade Medical, Inc. — 1 clearance

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

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