Data / Medical devices / Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ): 19 FDA-registered makers in 9 countries
19 establishments in 9 countries are registered with the FDA to make Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ, Class 2, 21 CFR 882.1400). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on October 9, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OLZ
- Device class
- 2
- Regulation
- 882.1400
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Iceland | 1 |
| Canada | 1 |
| Netherlands | 1 |
| Taiwan | 1 |
| Australia | 1 |
| Estonia | 1 |
| China | 1 |
| India | 1 |
Makers of Automatic Event Detection Software For Polysomnograph With 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 |
|---|---|---|---|---|---|---|---|---|
| Advanced Brain Monitoring, Inc. | Carlsbad, CA, United States | Manufacturer | 3 | March 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Nox Medical | Reykjavik, Iceland | Manufacturer | 3 | November 17, 2025 | 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 Medical Incorporated Dba Excel-Tech Ltd. (xltek) | OAKVILLE Ontario, Canada | Complaint file establishment, Manufacturer, Specification developer | 1 | April 19, 2011 | 0 | 0 | 0 | api.fda.gov |
| Natus Neurology Incorporated | Middleton, WI, United States | Manufacturer | 1 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Onera B.V. | Eindhoven Noord-Brabant, Netherlands | Manufacturer | 1 | March 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 1 | March 18, 2004 | 0 | 0 | 0 | api.fda.gov |
| Compal Electronics, Inc | Taoyuan City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Compumedics Limited | Melbourne Victoria, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huneo, LLC | Willoughby Hills, OH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innokas Medical Estonia Ou | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin Jiangsu, China | Contract manufacturer | 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 | |
| Philips India Limited - Sleep & Respiratory Care Business Unit | Bengaluru Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 9, 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.