Data / Medical devices / Automatic Event Detection Software For Full-Montage Electroencephalograph
Automatic Event Detection Software For Full-Montage Electroencephalograph (OMB): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Automatic Event Detection Software For Full-Montage Electroencephalograph (product code OMB, Class 2, 21 CFR 882.1400). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 42 510(k) clearances under this code, the latest on June 24, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OMB
- Device class
- 2
- Regulation
- 882.1400
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Japan | 3 |
| Canada | 1 |
| Austria | 1 |
| Norway | 1 |
Makers of Automatic Event Detection Software For Full-Montage Electroencephalograph
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek) | OAKVILLE Ontario, Canada | Complaint file establishment, Manufacturer, Specification developer | 6 | May 18, 2020 | 0 | 1 | 0 | api.fda.gov |
| Ceribell, Inc. | Sunnyvale, CA, United States | Manufacturer | 4 | November 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ait Austrian Institute Of Technology GMBH | Vienna Wien, Austria | Manufacturer | 3 | September 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Holberg Eeg AS | Bergen Hordaland, Norway | Manufacturer | 2 | April 9, 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 | |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | 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 | |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 24, 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.