BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IceCap 2 Neonate

    Reg #: 3027532607 · FEI: 3027532607 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ALLIANCE NEURODIAGNOSTICS, LLC, D/B/A STRATUS
    Registration Number
    3027532607
    FEI Number
    3027532607
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4545 Fuller Dr Ste 100
    City
    Irving
    State
    TX
    ZIP
    75038
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243788

    Owner / Operator

    Firm Name
    Alliance Neurodiagnostics, LLC, d/b/a Stratus
    Operator Number
    10091660
    Address
    4545 Fuller Dr., Suite 100
    City
    Irving
    State
    TX
    Postal Code
    75038
    Country
    US
    Correspondent
    Jennifer Armstrong

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY

    Proprietary Names

    IceCap 2 Neonate

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198