Data / Medical devices / Amplitude-Integrated Electroencephalograph
Amplitude-Integrated Electroencephalograph (OMA): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Amplitude-Integrated Electroencephalograph (product code OMA, 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 16 510(k) clearances under this code, the latest on January 30, 2020, and lists 3 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- OMA
- Device class
- 2
- Regulation
- 882.1400
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Japan | 3 |
| Canada | 1 |
| Germany | 1 |
| Austria | 1 |
| Ireland | 1 |
Makers of Amplitude-Integrated 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 |
|---|---|---|---|---|---|---|---|---|
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 4 | May 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 4 | May 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek) | OAKVILLE Ontario, Canada | Complaint file establishment, Manufacturer, Specification developer | 3 | June 3, 2016 | 0 | 2 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 3 | May 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 3 | May 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Eemagine Medical Imaging Solutions GMBH | Berlin, Germany | Manufacturer | 1 | January 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Natus Neurology Incorporated | Middleton, WI, United States | Contract manufacturer, Manufacturer | 1 | November 5, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ait Austrian Institute Of Technology GMBH | Vienna Wien, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LEAD-LOK, INC. d.b.a Nissha Medical Technologies | Sandpoint, ID, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lvis Corporation | Palo Alto, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Manufacturing Limited | GORT, Co. Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Persyst Development LLC | Solana Beach, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 30, 2020. 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.