BEUDAMED
    FDA Registration Active 🇦🇺 Australia

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    Reg #: 3017102960 · FEI: 3017102960 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
    Registration Number
    3017102960
    FEI Number
    3017102960
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Suite L1.108, 477 Pitt Street
    City
    Haymarket New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K203518

    Owner / Operator

    Firm Name
    Omniscient Neurotechnology Pty Ltd (o8t)
    Operator Number
    10080969
    Address
    Suite L1.108, 477 Pitt Street
    City
    Haymarket
    State
    New South Wales
    Postal Code
    2000
    Country
    AU
    Correspondent
    Arie Henkin

    US Agent

    Business Name
    Omniscient Neurotechnology America Ltd
    Contact Name
    Michael Sughrue
    Address
    9035 E Lupine Ave
    City
    Scottsdale
    State
    AZ
    ZIP
    85260
    Country
    US
    Email
    [email protected]
    Phone
    602 9896207

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Quicktome

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198