BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Pre-configured EEG Lead Set 2, General

    Reg #: 9610105 · FEI: 3002806783 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    GE HEALTHCARE FINLAND OY
    Registration Number
    9610105
    FEI Number
    3002806783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KUORTANEENKATU 2
    City
    HELSINKI Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K191322

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

    Proprietary Names

    Pre-configured EEG Lead Set 2, General N-EEGX E-EEGX Pre-configured EEG Lead Set 3, AEP Pre-configured EEG Lead Set 1 AEP Earphones Ear tips for earphone

    Establishment Types

    Manufacture Medical Device