BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arc Alterna

    Reg #: 3020018 · FEI: 3020018 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    CADWELL INDUSTRIES, INC.
    Registration Number
    3020018
    FEI Number
    3020018
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    909 N Kellogg St
    City
    KENNEWICK
    State
    WA
    ZIP
    99336
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133355

    Owner / Operator

    Firm Name
    CADWELL INDUSTRIES, INC.
    Operator Number
    3020018
    Address
    909 NORTH KELLOGG ST., --
    City
    Kennewick
    State
    WA
    Postal Code
    99336
    Country
    US
    Correspondent
    Becky Corral

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ
    Standard Polysomnograph With Electroencephalograph OLV
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Reduced- Montage Standard Electroencephalograph OMC
    Stimulator, Photic, Evoked Response GWE
    Amplifier, Physiological Signal GWL

    Proprietary Names

    Arc Alterna Arc Essentia Arc Synopsis Software ApneaTrak

    Establishment Types

    Manufacture Medical Device