FDA product code GWS: Analyzer, Spectrum, Electroencephalogram Signal
GWS is the FDA product code for analyzer, spectrum, electroencephalogram signal. It is a Class I device, regulated under 21 CFR 882.1420 and reviewed by the Neurology panel. FDA has cleared 15 510(k) submissions under GWS, from 12 different applicants. The average 510(k) review took 122 days (median 85).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Spectrum, Electroencephalogram Signal |
| Device class | Class I |
| Regulation | 21 CFR 882.1420 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GWS clearance
Top GWS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cns, Inc. | 3 | 1986-05-29 |
| Neuroscience, Inc. | 2 | 1987-10-13 |
| Persyst Development Corp. | 1 | 1998-03-09 |
| Bio-Scan, Inc. | 1 | 1993-12-03 |
| Stellate Systems | 1 | 1991-07-30 |
7 more applicants have GWS clearances. See the full list in Caduvo.
Most recent GWS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974718 | Persyst Development Corp. | PERSYST PRISM | 1998-03-09 | 82 |
| K925735 | Bio-Scan, Inc. | EEG ANALYZER | 1993-12-03 | 385 |
| K912938 | Stellate Systems | RHYTHM | 1991-07-30 | 25 |
| K894629 | Nicolet Instrument Corp. | NICOLET BEAM II SYSTEM | 1990-03-09 | 228 |
| K871931 | Neuroscience, Inc. | ISTAT SOFTWARE | 1987-10-13 | 147 |
Recalls for GWS devices
openFDA lists no recalls for product code GWS.
Frequently asked questions
What is FDA product code GWS?
GWS is the FDA product code for analyzer, spectrum, electroencephalogram signal. It is a Class I device, regulated under 21 CFR 882.1420 and reviewed by the Neurology panel.
What device class is GWS?
Class I, regulation 21 CFR 882.1420. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWS?
Across 15 cleared submissions the average was 122 days from receipt to decision (median 85).
Which companies have the most GWS clearances?
Cns, Inc. (3); Neuroscience, Inc. (2); Persyst Development Corp. (1); Bio-Scan, Inc. (1); Stellate Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GWS
- Run a recall and safety report across every GWS manufacturer
- Watch product code GWS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times