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Data / Medical devices / Full-Montage Standard Electroencephalograph / United States

FDA-registered makers of Full-Montage Standard Electroencephalograph in the United States: 35 establishments

35 establishments in the United States are registered with the FDA to make Full-Montage Standard Electroencephalograph (product code GWQ). 15 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

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Device
Full-Montage Standard Electroencephalograph
Product code
GWQ
Country
United States

Makers of Full-Montage Standard Electroencephalograph in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer4September 1, 2018000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer4August 25, 2017010api.fda.gov
Neurovirtual Usa, Inc.Fort Lauderdale, FL, United StatesManufacturer3April 24, 2020000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer3November 6, 2006060api.fda.gov
BSG CorpActon, MA, United StatesManufacturer2June 19, 2012000api.fda.gov
Blackrock MicrosystemsSalt Lake City, UT, United StatesManufacturer, Specification developer2May 2, 2013000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer2October 15, 2001010api.fda.gov
Advanced Brain Monitoring, Inc.Carlsbad, CA, United StatesManufacturer1November 27, 2013000api.fda.gov
Ambulatory Monitoring, Inc.Ardsley, NY, United StatesRepackager or relabeler, Specification developer1June 25, 1986000api.fda.gov
Brainmaster Technologies, Inc.Bedford, OH, United StatesManufacturer1January 26, 2016000api.fda.gov
Firefly Neuroscience, Inc.New York, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1December 13, 2017000api.fda.gov
Neurofield, Inc.Santa Barbara, CA, United StatesComplaint file establishment, Manufacturer1August 31, 2023000api.fda.gov
Spark Neuro, Inc.New York, NY, United StatesManufacturer1August 18, 2023000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer1March 2, 1994000api.fda.gov
Wavi CoDenver, CO, United StatesManufacturer1May 6, 2022010api.fda.gov
Burke L. Mays And Associates, Inc.Franklin, TN, United StatesManufacturer0000api.fda.gov
Beacon Biosignals - Cleveland SiteCleveland, OH, United StatesSpecification developer0000api.fda.gov
Ceribell, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Cirtronics CorporationMilford, NH, United StatesContract manufacturer0000api.fda.gov
Co-Ax Technology, Inc.Solon, OH, United StatesContract manufacturer0000api.fda.gov
Controltek, Inc.Vancouver, WA, United StatesContract manufacturer0000api.fda.gov
Ducommun LaBarge TechnologiesAppleton, WI, United StatesContract manufacturer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Magstim IncEugene, OR, United StatesManufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Neurotronics, LLCAlachua, FL, United StatesManufacturer0000api.fda.gov
Nihon Kohden America Fulfillment CenterFoothill Ranch, CA, United StatesManufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Universal Brain Inc.Palo Alto, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated November 2, 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.