Data / Medical devices / United States / Burke L. Mays And Associates, Inc.
Burke L. Mays And Associates, Inc.: FDA-registered device maker in Franklin, TN, United States, 1 510(k) clearance
Burke L. Mays And Associates, Inc. is registered with the FDA (registration 3005550372) in Franklin, TN, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 1, 2005. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005550372
- Address
- 315 Springhouse Cir, Franklin, TN, United States, 37067
- Owner or operator
- BURKE L. MAYS AND ASSOCIATES, INC. (9069716)
- Roles
- Manufacturer
- First device listed
- November 29, 2005
- Registered through
- 2026
- Brand names listed
- OMNIPRO SYSTEM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Manufacturer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 1, 2005 | K050143 | OMNIPRO SYSTEM | OLV | Substantially Equivalent | Mays and Associates, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Standard Polysomnograph With Electroencephalograph
Updated February 1, 2005. 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.