# GWS: Analyzer, Spectrum, Electroencephalogram Signal

- Device class: 1; regulation: 21 CFR 882.1420; FDA's rule: 510(k) required
- FDA decisions: 15
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1980: 2
- 1981: 1
- 1984: 1
- 1985: 2
- 1986: 3
- 1987: 2
- 1990: 1
- 1991: 1
- 1993: 1
- 1998: 1

## Most-cited predicates
- K912938: Rhythm (1991), cited by 3
- K844481: Neurolab II (1985), cited by 2
- K850430: Neuroscience Map-10 Eeg (1985), cited by 2
- K974718: Persyst Prism (1998), cited by 1

Source page: https://510kreport.com/product-code/GWS
Data by year (CSV): https://510kreport.com/product-code/GWS.csv