Analyzer, Spectrum, Electroencephalogram Signal
FDA product code GWS · Class I (low risk) · 21 CFR 882.1420 · Neurology
15510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974718 | Persyst PrismGWS · Traditional | Persyst Development Corp. | 03/09/1998SE |
| K925735 | EEG AnalyzerGWS · Traditional | Bio-Scan, Inc. | 12/03/1993SE |
| K912938 | RhythmGWS · Traditional | Stellate Systems | 07/30/1991SE |
| K894629 | Nicolet Beam II SystemGWS · Traditional | Nicolet Instrument Corp. | 03/09/1990SE |
| K871931 | Istat SoftwareGWS · Traditional | Neuroscience, Inc. | 10/13/1987SE |
| K871480 | STD-228 Spectral Trend DisplayGWS · Traditional | Grass-Telefactor Product Group | 05/01/1987SE |
| K854662 | OEE_7102 Eeg/Trend MonitorGWS · Traditional | Nihon Kohden America, Inc. | 08/20/1986SE |
| K860829 | CNS 4/8 and CT 48.1 SoftwareGWS · Traditional | Cns, Inc. | 05/29/1986SE |
| K854160 | CNS-16 & LTM 1.0 SoftwareGWS · Traditional | Cns, Inc. | 01/10/1986SE |
| K850430 | Neuroscience MAP-10 EEGGWS · Traditional | Neuroscience, Inc. | 07/17/1985SE |
| K844481 | Neurolab IIGWS · Traditional | Teca, Inc. | 05/20/1985SE |
| K844015 | Cerebral Tracer 1500 & CT 1.0 SoftwareGWS · Traditional | Cns, Inc. | 12/17/1984SE |
| K803233 | Meurometrics MonitorGWS · Traditional | Dade Medical, Inc. | 01/12/1981SE |
| K800452 | Neurometrics MonitorGWS · Traditional | Neurometrics | 04/02/1980SE |
| K800001 | Mini-Cears Computer (Model 1)GWS · Traditional | Bik Foundation, Inc. | 01/31/1980SE |