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Data / Medical devices / Non-Normalizing Quantitative Electroencephalograph Software / United States

FDA-registered makers of Non-Normalizing Quantitative Electroencephalograph Software in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Non-Normalizing Quantitative Electroencephalograph Software (product code OLT). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
Non-Normalizing Quantitative Electroencephalograph Software
Product code
OLT
Country
United States

Makers of Non-Normalizing Quantitative Electroencephalograph Software in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer2October 9, 2025000api.fda.gov
Pascall Systems IncCambridge, MA, United StatesComplaint file establishment, Manufacturer2August 19, 2026000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesManufacturer1June 24, 1999000api.fda.gov
Magstim IncEugene, OR, United StatesManufacturer1February 12, 2014000api.fda.gov
Neuronetrix Solutions, LLCLouisville, KY, United StatesSpecification developer1February 13, 2015000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesManufacturer, Specification developer1December 17, 2019000api.fda.gov
Nihon Kohden America Fulfillment CenterFoothill Ranch, CA, United StatesManufacturer1October 9, 2025000api.fda.gov
Universal Brain Inc.Palo Alto, CA, United StatesComplaint file establishment, Specification developer1June 30, 2026000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer0000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer0000api.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
Lvis CorporationPalo Alto, CA, United StatesComplaint file establishment, 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
Neurofield, Inc.Santa Barbara, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Neurotronics, LLCAlachua, FL, United StatesManufacturer0000api.fda.gov
Neurowave Systems Inc.Beachwood, OH, United StatesManufacturer0000api.fda.gov
Persyst Development LLCSolana Beach, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Soterix Medical,inc.Woodbridge, NJ, United StatesManufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer0000api.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.