BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    CARESCAPE MONITOR B450

    Reg #: 9610105 · FEI: 3002806783 · Expires 2025
    View on FDA
    Products
    33
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    33

    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
    K132533

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

    Proprietary Names

    CARESCAPE MONITOR B450 CARESCAPE Monitor B450 BEDRAIL HOOK: BEDRAIL HOOK UNIT CARESCAPE MONITOR B450-LI CARESCAPE B450 BRH

    Establishment Types

    Manufacture Medical Device