BEUDAMED
    FDA Registration Active 🇨🇳 China

    E-EEG Datex-Ohmeda S/5 EEG Headbox

    Reg #: 9710602 · FEI: 3003513129 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS (CHINA) CO., LTD.
    Registration Number
    9710602
    FEI Number
    3003513129
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 19 CHANGJIANG ROAD, NATIONAL HI-TECH DEV. ZONE
    City
    WUXI Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K051883

    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

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    Stimulator, Auditory, Evoked Response GWJ
    Burst Suppression Detection Software For Electroencephalograph ORT
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Reduced- Montage Standard Electroencephalograph OMC
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Monitor, St Segment With Alarm MLD

    Proprietary Names

    E-EEG Datex-Ohmeda S/5 EEG Headbox Datex-Ohmeda S/5 EEG Module AEP Ear Tips for Earphone Set EEG Lead set 3 EEG Lead set 1

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility