BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENGSTROM PRO Ventilators

    Reg #: 2112667 · FEI: 2112667 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Datex-Ohmeda, Inc.
    Registration Number
    2112667
    FEI Number
    2112667
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3030 Ohmeda Drive
    City
    MADISON
    State
    WI
    ZIP
    53718
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111116

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    ENGSTROM PRO Ventilators GE Datex-Ohmeda ENGSTROM CARESTATION Engstrom Carestation Engstrom Pro

    Establishment Types

    Manufacture Medical Device