GWQClass II
Full-Montage Standard Electroencephalograph
21 CFR 882.1400 / Neurology
GWQ is the FDA product code for Full-Montage Standard Electroencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations". As of , FDA records hold 189 510(k) clearances under this code, the most recent dated , and 23 recalls.
Classification record
- Product code
- GWQ
- Device name
- Full-Montage Standard Electroencephalograph
- FDA definition
- Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
- Regulation
- 21 CFR 882.1400
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 189
- Ingested recalls
- 23
Clearances, product code GWQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 3 |
| 1979 | 3 |
| 1980 | 3 |
| 1982 | 8 |
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 4 |
| 1986 | 7 |
| 1987 | 6 |
| 1988 | 4 |
| 1989 | 4 |
| 1990 | 5 |
| 1991 | 8 |
| 1992 | 6 |
| 1993 | 7 |
| 1994 | 5 |
| 1995 | 5 |
| 1996 | 3 |
| 1997 | 7 |
| 1998 | 4 |
| 1999 | 4 |
| 2000 | 5 |
| 2001 | 11 |
| 2002 | 4 |
| 2003 | 1 |
| 2004 | 5 |
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2010 | 3 |
| 2011 | 4 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 5 |
| 2018 | 8 |
| 2020 | 6 |
| 2022 | 3 |
| 2023 | 6 |
| 2024 | 1 |
| 2026 | 2 |
Applicants with the most clearances
Product code GWQ| Applicant | Clearances |
|---|---|
| Excel Tech., Ltd. | 15 |
| Nihon Kohden America Inc | 15 |
| Del Mar Avionics | 7 |
| Natus Medical Incorporated | 6 |
| Oxford Medilog, Inc. | 6 |
| Bio-Logic Systems Corp. | 5 |
| Physiometrix, Inc. | 5 |
| Teca, Inc. | 5 |
| Axon Systems, Inc. | 4 |
| Cadwell Industries Inc | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Advanced Brain Monitoring, Inc.
- Alliance Neurodiagnostics, LLC, D/B/a Stratus
- Alpha Omega Engineering Ltd.
- Ambulatory Monitoring, Inc.
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Beacon Bio Dx, LLC dba CleveMed
- Bee Medic GmbH
- BEE Systems, Inc
- Blackrock Microsystems
- Brainmaster Technologies, Inc.
- BSG Corp
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.