Data / Medical devices / Automatic Event Detection Software For Full-Montage Electroencephalograph / United States
FDA-registered makers of Automatic Event Detection Software For Full-Montage Electroencephalograph in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Automatic Event Detection Software For Full-Montage Electroencephalograph (product code OMB). 4 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
- Automatic Event Detection Software For Full-Montage Electroencephalograph
- Product code
- OMB
- Country
- United States
Makers of Automatic Event Detection Software For Full-Montage Electroencephalograph in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Persyst Development LLC | Solana Beach, CA, United States | Complaint file establishment, Manufacturer | 7 | October 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ceribell, Inc. | Sunnyvale, CA, United States | Manufacturer | 4 | November 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Lvis Corporation | Palo Alto, CA, United States | Complaint file establishment, Manufacturer | 2 | November 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Epitel | Salt Lake City, UT, United States | Manufacturer | 1 | January 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.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.