Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005550372

FEI Number

3005550372

Entity Name

BURKE L. MAYS AND ASSOCIATES, INC.

City/State/Country

FRANKLIN, TN, US

Establishment Address

315 SPRINGHOUSE CIR, FRANKLIN, TN 37067, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BURKE L. MAYS AND ASSOCIATES, INC. (Owner Number: 9069716)

Owner / Operator Contact Address

315 SPRINGHOUSE CIRCLE, --, Franklin, TN 37067, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050143

PMA Number

N/A

All Registered Proprietary Names

OMNIPRO SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2005-11-29
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2005-11-29

Official Correspondent

BURKE MAYS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BURKE L. MAYS AND ASSOCIATES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005550372. Last updated year: 2026. Please use registration number 3005550372 when referencing this establishment in official correspondence.