Data / Medical devices / Standard Polysomnograph With Electroencephalograph / United States
FDA-registered makers of Standard Polysomnograph With Electroencephalograph in the United States: 18 establishments
18 establishments in the United States are registered with the FDA to make Standard Polysomnograph With Electroencephalograph (product code OLV). 9 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Standard Polysomnograph With Electroencephalograph
- Product code
- OLV
- Country
- United States
Makers of Standard Polysomnograph With Electroencephalograph in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Neurotronics, LLC | Alachua, FL, United States | Manufacturer | 5 | November 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 5 | January 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Consolidated Research, Inc. | Euclid, OH, United States | Manufacturer | 2 | December 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Beacon Biosignals, Inc. | Boston, MA, United States | Manufacturer | 1 | August 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Burke L. Mays And Associates, Inc. | Franklin, TN, United States | Manufacturer | 1 | February 1, 2005 | 0 | 0 | 0 | api.fda.gov |
| Beacon Biosignals - Cleveland Site | Cleveland, OH, United States | Specification developer | 1 | November 17, 2004 | 0 | 0 | 0 | api.fda.gov |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer | 1 | February 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Natus Neurology Incorporated | Middleton, WI, United States | Complaint file establishment, Contract manufacturer, Specification developer | 1 | July 12, 2002 | 0 | 1 | 0 | api.fda.gov |
| Nihon Kohden America Fulfillment Center | Foothill Ranch, CA, United States | Manufacturer | 1 | April 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Advanced Brain Monitoring, Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blackrock Microsystems | Salt Lake City, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ducommun LaBarge Technologies | Appleton, WI, United States | Contract 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 | |
| Kimball Solutions Jasper, Inc. | Jasper, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirac, LLC | Lynchburg, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurovirtual Usa, Inc. | Fort Lauderdale, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics, Inc. | Mount Pleasant, PA, 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.