BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    F2 Frame (F2-01)

    Reg #: 3008729547 · FEI: 3008729547 · Expires 2025
    View on FDA
    Products
    35
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    35

    Registration Details

    Registration Name
    GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.
    Registration Number
    3008729547
    FEI Number
    3008729547
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CALLE VALLE DEL CEDRO 1551
    City
    JUAREZ Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K223531

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

    Proprietary Names

    F2 Frame (F2-01) CARESCAPE Canvas 1000 CARESCAPE Canvas Smart Display CARESCAPE Canvas D19

    Establishment Types

    Manufacture Medical Device