Data / Medical devices / United States / Neurofield, Inc.
Neurofield, Inc.: FDA-registered device maker in Santa Barbara, CA, United States, 3 510(k) clearances
Neurofield, Inc. is registered with the FDA (registration 3010900508) in Santa Barbara, CA, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010900508
- Address
- 1836 State St, Santa Barbara, CA, United States, 93101
- Owner or operator
- Neurofield, Inc. (10046907)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 20, 2023
- Registered through
- 2026
- Brand names listed
- Genesis, NeuroField Analysis Suite, Q-Check, Q21
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | QJQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Normalizing Quantitative Electroencephalograph Software | OLU | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tester, Electrode/Lead, Electroencephalograph | GYA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 31, 2025 | K252951 | Genesis Sleep | QJQ | Substantially Equivalent | Neurofield, Inc. | accessdata.fda.gov |
| September 20, 2024 | K240420 | NeuroField Analysis Suite | OLU | Substantially Equivalent | Neurofield, Inc. | accessdata.fda.gov |
| August 31, 2023 | K221959 | Q21 | GWQ | Substantially Equivalent | Neurofield, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Normalizing Quantitative Electroencephalograph Software
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Tester, Electrode/Lead, Electroencephalograph
Updated December 31, 2025. 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.