Data / Medical devices / Full-Montage Standard Electroencephalograph
Full-Montage Standard Electroencephalograph (GWQ): 77 FDA-registered makers in 22 countries
77 establishments in 22 countries are registered with the FDA to make Full-Montage Standard Electroencephalograph (product code GWQ, Class 2, 21 CFR 882.1400). 30 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 189 510(k) clearances under this code, the latest on June 13, 2026, and lists 21 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GWQ
- Device class
- 2
- Regulation
- 882.1400
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 35 |
| Japan | 5 |
| Germany | 5 |
| United Kingdom | 4 |
| Canada | 3 |
| China | 3 |
| Mexico | 3 |
| South Korea | 2 |
| Italy | 2 |
| Austria | 2 |
| Poland | 2 |
| Australia | 1 |
| Hungary | 1 |
| Finland | 1 |
| Bulgaria | 1 |
| Spain | 1 |
| Israel | 1 |
| Iceland | 1 |
| Malaysia | 1 |
| Russia | 1 |
| Taiwan | 1 |
| India | 1 |
Makers of Full-Montage Standard Electroencephalograph
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek) | OAKVILLE Ontario, Canada | Complaint file establishment, Manufacturer, Specification developer | 9 | June 14, 2018 | 0 | 3 | 0 | api.fda.gov |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer | 4 | September 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| Compumedics Limited | Melbourne Victoria, Australia | Complaint file establishment, Exporter to the US, Manufacturer | 4 | February 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 4 | August 25, 2017 | 0 | 1 | 0 | api.fda.gov |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 4 | August 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 4 | August 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Neurovirtual Usa, Inc. | Fort Lauderdale, FL, United States | Manufacturer | 3 | April 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Natus Neurology Incorporated | Middleton, WI, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 3 | November 6, 2006 | 0 | 6 | 0 | api.fda.gov |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 3 | August 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Zeto EU Kft. | Szeged, Hungary | Manufacturer, Repackager or relabeler | 3 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| BSG Corp | Acton, MA, United States | Manufacturer | 2 | June 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| Blackrock Microsystems | Salt Lake City, UT, United States | Manufacturer, Specification developer | 2 | May 2, 2013 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Specification developer | 2 | October 15, 2001 | 0 | 1 | 0 | api.fda.gov |
| Advanced Brain Monitoring, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | November 27, 2013 | 0 | 0 | 0 | api.fda.gov |
| Ambulatory Monitoring, Inc. | Ardsley, NY, United States | Repackager or relabeler, Specification developer | 1 | June 25, 1986 | 0 | 0 | 0 | api.fda.gov |
| Bee Medic GMBH | Bamberg Bavaria, Germany | Manufacturer | 1 | December 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Brainmaster Technologies, Inc. | Bedford, OH, United States | Manufacturer | 1 | January 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| Cumulus Neuroscience | Belfast Antrim and Newtownabbey, United Kingdom | Complaint file establishment, Manufacturer | 1 | April 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Eemagine Medical Imaging Solutions GMBH | Berlin, Germany | Manufacturer | 1 | September 12, 2005 | 0 | 0 | 0 | api.fda.gov |
| Firefly Neuroscience, Inc. | New York, NY, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | December 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer, Specification developer | 1 | July 19, 2011 | 0 | 0 | 0 | api.fda.gov |
| Imedisync Inc. | Gangnam-gu Seoul, South Korea | Manufacturer | 1 | August 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Lifelines Ltd. | WOKING Surrey, United Kingdom | Specification developer | 1 | May 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Medeia Group Ltd | Sofia Sofia-Grad, Bulgaria | Manufacturer | 1 | March 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Neuroelectrics Barcelona S.L.U. | Barcelona Catalonia, Spain | Complaint file establishment, Exporter to the US, Manufacturer | 1 | June 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Neurofield, Inc. | Santa Barbara, CA, United States | Complaint file establishment, Manufacturer | 1 | August 31, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Corporation | Gunma Tokyo, Japan | Manufacturer | 1 | July 29, 2011 | 0 | 0 | 0 | api.fda.gov |
| Spark Neuro, Inc. | New York, NY, United States | Manufacturer | 1 | August 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 1 | March 2, 1994 | 0 | 0 | 0 | api.fda.gov |
| Wavi Co | Denver, CO, United States | Manufacturer | 1 | May 6, 2022 | 0 | 1 | 0 | api.fda.gov |
| Alpha Omega Engineering Ltd. | Nof HaGalil Northern, Israel | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burke L. Mays And Associates, Inc. | Franklin, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beacon Biosignals - Cleveland Site | Cleveland, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ceribell, Inc. | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemigraphic Ltd | Crawley West Sussex, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtronics Corporation | Milford, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Co-Ax Technology, Inc. | Solon, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Controltek, Inc. | Vancouver, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ducommun LaBarge Technologies | Appleton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eb Neuro S.P.A. | Arbizzano di Valpolicella Verona, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eb Neuro, S.P.A. | FLORENCE Tuscany, Italy | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ems Handels Gesellschaft M.B.H. | Korneuburg Niederosterreich, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epm Global Services Inc., Dba Vexos | Markham Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fideltronik Poland SP. Z O.O. | Sucha Beskidzka Malopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inomed Medizintechnik GMBH | EMMENDINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrial Vallera de Mexicali, S.A. de C.V. (Terra) | Mexicali Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kvikna Medical ehf | Reykjavik, Iceland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leonhard Lang GMBH | INNSBRUCK Tirol, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lidco Ltd. | LONDON England, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) | GANANOQUE Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magstim Inc | Eugene, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Medical Technologies (Malaysia) SDN BHD | Pasir Gudang Johor, Malaysia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurosoft Ltd | Ivanovo Ivanovskaya Oblast', Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurotronics, LLC | Alachua, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nicolay GMBH | NAGOLD Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden America Fulfillment Center | Foothill Ranch, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Vinyl Cord Corporation - Kodama Second Factory | Honjo-shi Saitama, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Export, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Universal Brain Inc. | Palo Alto, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xian Friendship Medical Electronics Co., Ltd. | Xi'an Shaanxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ybrain Inc. | Daejeon, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.