BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Okti 128 Ch Ambulatory EEG Recorder Only

    Reg #: 9613619 · FEI: 3004674371 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    COMPUMEDICS LIMITED
    Registration Number
    9613619
    FEI Number
    3004674371
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30-40 Flockhart Street,, Abbotsford,
    City
    Melbourne Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K230073

    Owner / Operator

    Firm Name
    Compumedics
    Operator Number
    10027560
    Address
    30-40 Flockhart Street
    City
    Abbotsford
    State
    Victoria
    Postal Code
    3067
    Country
    AU
    Correspondent
    John Joseph

    US Agent

    Business Name
    Compumedics USA Ltd
    Contact Name
    Steve Johnson
    Address
    5015 W W T Harris Blvd Ste E
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US
    Email
    [email protected]
    Phone
    704 7493200 ext. 5

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    Okti 128 Ch Ambulatory EEG Recorder Only Okti 32 Ch Ambulatory EEG System Okti 128 Ch Ambulatory EEG System Okti Ethernet Connection Kit Okti 32 Ch Ambulatory EEG Recorder Only Okti 64 Ch Ambulatory EEG Recorder Only Okti 64 Ch Ambulatory EEG System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device