Data / Medical devices / Automatic Event Detection Software For Polysomnograph With Electroencephalograph / United States
FDA-registered makers of Automatic Event Detection Software For Polysomnograph With Electroencephalograph in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ). 8 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 Polysomnograph With Electroencephalograph
- Product code
- OLZ
- Country
- United States
Makers of Automatic Event Detection Software For Polysomnograph With Electroencephalograph in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Advanced Brain Monitoring, Inc. | Carlsbad, CA, United States | Manufacturer | 3 | March 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Beacon Biosignals, Inc. | Boston, MA, United States | Manufacturer | 2 | November 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ensodata, Inc. | Madison, WI, United States | Manufacturer | 2 | June 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Belco. LLC | Eugene, OR, United States | Manufacturer | 1 | April 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Consolidated Research, Inc. | Euclid, OH, United States | Manufacturer | 1 | January 20, 2015 | 0 | 0 | 0 | api.fda.gov |
| Natus Neurology Incorporated | Middleton, WI, United States | Manufacturer | 1 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 1 | March 18, 2004 | 0 | 0 | 0 | api.fda.gov |
| Huneo, LLC | Willoughby Hills, OH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions Jasper, Inc. | Jasper, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurotronics, LLC | Alachua, FL, United States | 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.