BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRACK IT

    Reg #: 3015491430 · FEI: 3015491430 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Lifelines Neuro Company
    Registration Number
    3015491430
    FEI Number
    3015491430
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    900 East Main Street, STE 300
    City
    Louisville
    State
    KY
    ZIP
    40206
    Country
    US

    Regulatory Submissions

    510(k) Number
    K010460

    Owner / Operator

    Firm Name
    LIFELINES LTD.
    Operator Number
    9044781
    Address
    1 TANNERY HOUSE, TANNERY LANE
    City
    WOKING
    State
    Surrey
    Postal Code
    GU23 7EF
    Country
    GB
    Correspondent
    Chloe A Mayo

    Products

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

    Proprietary Names

    TRACK IT Trackit MK3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198