GWS · Analyzer, Spectrum, Electroencephalogram Signal
Neurology · 21 CFR 882.1420 · Class 1
Overview
| Product Code | GWS |
|---|---|
| Device Name | Analyzer, Spectrum, Electroencephalogram Signal |
| Regulation | 21 CFR 882.1420 |
| Device Class | Class 1 |
| Review Panel | Neurology |
| 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).
Cleared Devices (15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974718 | PERSYST PRISM | Persyst Development Corp. | Mar 9, 1998 | SESE |
| K925735 | EEG ANALYZER | Bio-Scan, Inc. | Dec 3, 1993 | SESE |
| K912938 | RHYTHM | Stellate Systems | Jul 30, 1991 | SESE |
| K894629 | NICOLET BEAM II SYSTEM | Nicolet Instrument Corp. | Mar 9, 1990 | SESE |
| K871931 | ISTAT SOFTWARE | Neuroscience, Inc. | Oct 13, 1987 | SESE |
| K871480 | STD-228 SPECTRAL TREND DISPLAY | Grass-Telefactor Product Group | May 1, 1987 | SESE |
| K854662 | OEE_7102 EEG/TREND MONITOR | Nihon Kohden America, Inc. | Aug 20, 1986 | SESE |
| K860829 | CNS 4/8 AND CT 48.1 SOFTWARE | Cns, Inc. | May 29, 1986 | SESE |
| K854160 | CNS-16 & LTM 1.0 SOFTWARE | Cns, Inc. | Jan 10, 1986 | SESE |
| K850430 | NEUROSCIENCE MAP-10 EEG | Neuroscience, Inc. | Jul 17, 1985 | SESE |
| K844481 | NEUROLAB II | Teca, Inc. | May 20, 1985 | SESE |
| K844015 | CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE | Cns, Inc. | Dec 17, 1984 | SESE |
| K803233 | MEUROMETRICS MONITOR | Dade Medical, Inc. | Jan 12, 1981 | SESE |
| K800452 | NEUROMETRICS MONITOR | Neurometrics | Apr 2, 1980 | SESE |
| K800001 | MINI-CEARS COMPUTER (MODEL 1) | Bik Foundation, Inc. | Jan 31, 1980 | SESE |
Top Applicants
- Cns, Inc. — 3 clearances
- Neuroscience, Inc. — 2 clearances
- Teca, Inc. — 1 clearance
- Stellate Systems — 1 clearance
- Persyst Development Corp. — 1 clearance
