BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    Stratus EEG

    Reg #: 3011047165 · FEI: 3011047165 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Kvikna Medical ehf
    Registration Number
    3011047165
    FEI Number
    3011047165
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lynghals 9
    City
    Reykjavik
    Country
    IS

    Regulatory Submissions

    510(k) Number
    K143487

    Owner / Operator

    Firm Name
    Kvikna Medical ehf
    Operator Number
    10051556
    Address
    Lynghals 9
    City
    Reykjavik
    State
    IS-55
    Postal Code
    110
    Country
    IS
    Correspondent
    Gardar Thorvardsson

    US Agent

    Business Name
    Stratus
    Contact Name
    David Hruda
    Address
    4545 Fuller Dr Ste 100
    City
    Irving
    State
    TX
    ZIP
    75038
    Country
    US
    Email
    [email protected]
    Phone
    301 7525700

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ
    Non-Normalizing Quantitative Electroencephalograph Software OLT

    Proprietary Names

    Stratus EEG

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility