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

FDA-registered makers of Reduced- Montage Standard Electroencephalograph in the United States: 27 establishments

27 establishments in the United States are registered with the FDA to make Reduced- Montage Standard Electroencephalograph (product code OMC). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Reduced- Montage Standard Electroencephalograph
Product code
OMC
Country
United States

Makers of Reduced- Montage Standard Electroencephalograph in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Advanced Brain Monitoring, Inc.Carlsbad, CA, United StatesManufacturer3October 30, 2015000api.fda.gov
Blackrock MicrosystemsSalt Lake City, UT, United StatesManufacturer1March 28, 2006000api.fda.gov
Ceribell, Inc.Sunnyvale, CA, United StatesManufacturer1May 8, 2017000api.fda.gov
EpitelSalt Lake City, UT, United StatesManufacturer1March 21, 2025000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer1March 19, 2019000api.fda.gov
Neuralynx, Inc.Bozeman, MT, United StatesManufacturer1June 30, 2011000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer0000api.fda.gov
Consolidated Research, Inc.Euclid, OH, United StatesManufacturer0000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesManufacturer0000api.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
Happy HealthAustin, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
LEAD-LOK, INC. d.b.a Nissha Medical TechnologiesSandpoint, ID, United StatesContract manufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Mirac, LLCLynchburg, OH, United StatesContract manufacturer0000api.fda.gov
Neuronetrix Solutions, LLCLouisville, KY, United StatesSpecification developer0000api.fda.gov
Neurowave Systems Inc.Beachwood, OH, United StatesManufacturer0000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesContract manufacturer0000api.fda.gov
Occam DesignLouisville, KY, United StatesContract manufacturer0000api.fda.gov
Pascall Systems IncCambridge, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer0000api.fda.gov
White Dove Global Marketing, LtdCommerce Township, MI, United StatesContract manufacturer0000api.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.