BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HemoSphere ForeSight Oximeter Cable

    Reg #: 2015691 · FEI: 2015691 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES LLC
    Registration Number
    2015691
    FEI Number
    2015691
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ONE EDWARDS WAY
    City
    IRVINE
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223865

    Owner / Operator

    Firm Name
    Edwards Lifesciences LLC
    Operator Number
    9040666
    Address
    One Edwards Way
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Denny Kouri

    Products

    Device Name Product Code
    Plethysmograph, Impedance DSB
    Computer, Diagnostic, Programmable DQK
    Oximeter, Tissue Saturation MUD
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Continuous Measurement Thermometer FLL
    Adjunctive Open Loop Fluid Therapy Recommender QMS
    Catheter, Oximeter, Fiber-Optic DQE

    Proprietary Names

    HemoSphere ForeSight Oximeter Cable ViewFinder Remote HemoSphere Pressure Cable Acumen IQ sensor with 84” (213cm) pressure tubing, Acumen IQ fluid meter, 5-pack Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter HemoSphere ClearSight Module HemoSphere VitaWave Module Acumen IQ fluid meter HemoSphere Swan-Ganz Module HemoSphere Oximetry Cable HemoSphere Vita Technology Module Acumen AFM Cable Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult, 5-pack Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult with TruWave DPT, 5-pack HemoSphere Vita Monitor HemoSphere Advanced Monitor Heart Reference Sensor Acumen IQ sensor with 84” (213cm) pressure tubing with Acumen IQ fluid meter Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter, 5-pack Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult HemoSphere Technology Module Pressure Controller Kit

    Establishment Types

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