Data / Medical devices / Index-Generating Electroencephalograph Software / United States
FDA-registered makers of Index-Generating Electroencephalograph Software in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Index-Generating Electroencephalograph Software (product code OLW). 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
- Index-Generating Electroencephalograph Software
- Product code
- OLW
- Country
- United States
Makers of Index-Generating Electroencephalograph Software in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Covidien | Lafayette, CO, United States | Specification developer | 1 | August 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | February 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Neurowave Systems Inc. | Beachwood, OH, United States | Manufacturer | 1 | August 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 1 | June 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 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.