BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Okti 32 Ch Ambulatory EEG System

    Reg #: 1650946 · FEI: 3002716534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COMPUMEDICS USA, INC.
    Registration Number
    1650946
    FEI Number
    3002716534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5015 West WT Harris Blvd, Suite E
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230073

    Owner / Operator

    Firm Name
    Compumedics USA Inc.
    Operator Number
    9029712
    Address
    5015 W W.T. Harris Blvd, Suite E
    City
    Charlotte
    State
    NC
    Postal Code
    28269
    Country
    US
    Correspondent
    Bailey K Lewis

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198