GWS
15 FDA 510(k) clearances · Product code
85 daysmedian time to decision
273 days90th percentile
15clearances measured
FDA profile
- Official device name
- Analyzer, Spectrum, Electroencephalogram Signal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 882.1420
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PERSYST PRISM (K974718) | Persyst Development Corp. | 1998-03-09 |
| EEG ANALYZER (K925735) | Bio-Scan, Inc. | 1993-12-03 |
| RHYTHM (K912938) | Stellate Systems | 1991-07-30 |
| NICOLET BEAM II SYSTEM (K894629) | Nicolet Instrument Corp. | 1990-03-09 |
| ISTAT SOFTWARE (K871931) | Neuroscience, Inc. | 1987-10-13 |
| STD-228 SPECTRAL TREND DISPLAY (K871480) | Grass-Telefactor Product Group | 1987-05-01 |
| OEE_7102 EEG/TREND MONITOR (K854662) | Nihon Kohden America, Inc. | 1986-08-20 |
| CNS 4/8 AND CT 48.1 SOFTWARE (K860829) | Cns, Inc. | 1986-05-29 |
| CNS-16 & LTM 1.0 SOFTWARE (K854160) | Cns, Inc. | 1986-01-10 |
| NEUROSCIENCE MAP-10 EEG (K850430) | Neuroscience, Inc. | 1985-07-17 |
| NEUROLAB II (K844481) | Teca, Inc. | 1985-05-20 |
| CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE (K844015) | Cns, Inc. | 1984-12-17 |
| MEUROMETRICS MONITOR (K803233) | Dade Medical, Inc. | 1981-01-12 |
| NEUROMETRICS MONITOR (K800452) | Neurometrics | 1980-04-02 |
| MINI-CEARS COMPUTER (MODEL 1) (K800001) | Bik Foundation, Inc. | 1980-01-31 |
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