BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    TruSignal SpO2 Sensitive Skin (TS-SE-3)

    Reg #: 9610105 · FEI: 3002806783 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    2

    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
    K093881

    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
    Oximeter, Ear DPZ
    Oximeter DQA

    Proprietary Names

    TruSignal SpO2 Sensitive Skin (TS-SE-3) TruSignal SpO2 Interconnect Cable with Datex connector (TS-N3) TruSignal SpO2 Interconnect Cable with Trusat connector (TS-M3) TruSignal SpO2 Interconnect Cable with GE connector (TS-G3) TruSignal SpO2 Finger Sensor (TS-F-D) TruSignal SpO2 Ear Sensor (TS-E-D) TruSignal SpO2 Interconnect Cable with Ohmeda connector (TS-H3) TruSignal SpO2 attachment accessories (TS-HB-3, TS-RWL-24, TS-RTW-100, TS-SND-3, TS-RWS-24, TS-RWM-24)

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device