BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Portrait SpO2 P-W01

    Reg #: 1651104 · FEI: 3002737156 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Registration Number
    1651104
    FEI Number
    3002737156
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    465 PAN AMERICAN DR STE 11
    City
    EL PASO
    State
    TX
    ZIP
    79907
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234130

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

    Proprietary Names

    Portrait SpO2 P-W01 Portrait RRP01 Portrait BCH01 Portrait SBT01 Portrait MMP01 Portrait CVAXB Portrait CAU01 Portrait Core Services CSSXB Portrait HUBXB Portrait RR P-RR01 Portrait AAB01 Portrait SpO2 P-SP01 Portrait SpO2 P-SA01 Portrait SpO2 P-SE01 Portrait HSWXB

    Establishment Types

    Manufacture Medical Device