BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01)

    Reg #: 9610105 · FEI: 3002806783 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    5

    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
    K230626

    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
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Breathing Frequency BZQ
    Oximeter DQA
    System, Network And Communication, Physiological Monitors MSX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG

    Proprietary Names

    Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01) Portrait™ Bedside Charger (Portrait BCH01) Portrait™ Mobile Patient Monitor (Portrait HUB01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01) Portrait™ Sensor Battery (Portrait SBT01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait™ Clinical Alarming Unit (Portrait CAU01) Portrait™ Core Services (Portrait CSS01) Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01) Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01) Portrait™ RR Electrode Patch (Portrait RRP01) Portrait™ Central Viewer Application (Portrait CVA01)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device