BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OMNIPRO SYSTEM

    Reg #: 3005550372 · FEI: 3005550372 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BURKE L. MAYS AND ASSOCIATES, INC.
    Registration Number
    3005550372
    FEI Number
    3005550372
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    315 SPRINGHOUSE CIR
    City
    FRANKLIN
    State
    TN
    ZIP
    37067
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050143

    Owner / Operator

    Firm Name
    BURKE L. MAYS AND ASSOCIATES, INC.
    Operator Number
    9069716
    Address
    315 SPRINGHOUSE CIRCLE, --
    City
    Franklin
    State
    TN
    Postal Code
    37067
    Country
    US
    Correspondent
    BURKE L MAYS

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    OMNIPRO SYSTEM

    Establishment Types

    Manufacture Medical Device