BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600

    Reg #: 3003207908 · FEI: 3003207908 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GCE, s.r.o.
    Registration Number
    3003207908
    FEI Number
    3003207908
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GCE, s.r.o., Zizkova 381
    City
    Chotebor Havlickuv Brod
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K162433

    Owner / Operator

    Firm Name
    GCE s.r.o.
    Operator Number
    10080413
    Address
    GCE s.r.o., Zizkova 381
    City
    Chotebor
    State
    Havlickuv Brod
    Postal Code
    58301
    Country
    CZ
    Correspondent
    Lukas Palek

    US Agent

    Business Name
    Ohio Medical, LLC
    Contact Name
    Jessica Barrile
    Address
    1111 Lakeside Drive
    City
    Gurnee
    State
    IL
    ZIP
    60031
    Country
    US
    Email
    [email protected]
    Phone
    847 8556318

    Products

    Device Name Product Code
    Generator, Oxygen, Portable CAW

    Proprietary Names

    GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600 GCE Zen-O Lite Clarity Portable Oxygen Concentrator Model RS-00600C ARYA ZenO Lite Portable Oxygen Concentrator RS-00600 GCE Zen-O Portable Oxygen Concentrator Model RS-00500 GCE Zen-O Clarity Portable Oxygen Concentrator Model RS-00500C

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)