BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Monitor B155M

    Reg #: 3012359877 · FEI: 3012359877 · Expires 2025
    View on FDA
    Products
    27
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    27

    Registration Details

    Registration Name
    GE Medical Systems Information Technologies, Inc.
    Registration Number
    3012359877
    FEI Number
    3012359877
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9900 Innovation Drive
    City
    Wauwatosa
    State
    WI
    ZIP
    53226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213490

    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
    Stimulator, Nerve, Peripheral, Electric KOI
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Breathing Frequency BZQ
    Oximeter, Ear DPZ
    Computer, Diagnostic, Programmable DQK
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Oximeter DQA
    Probe, Thermodilution KRB
    Index-Generating Electroencephalograph Software OLW
    Reduced- Montage Standard Electroencephalograph OMC
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Burst Suppression Detection Software For Electroencephalograph ORT
    Full-Montage Standard Electroencephalograph GWQ
    Continuous Measurement Thermometer FLL
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Computer, Blood-Pressure DSK
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Detector And Alarm, Arrhythmia DSI
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Monitor, St Segment With Alarm MLD
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Alarm, Blood-Pressure DSJ

    Proprietary Names

    Monitor B155M Monitor B105P B125M Patient Monitor Monitor B125M Monitor B125P B105M Patient Monitor B1X5-F2, Second Frame B125P Patient Monitor Monitor B105M B105P Patient Monitor B155M Patient Monitor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility