BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HemoSphere Advanced Monitor (HEM1)

    Reg #: 2015691 · FEI: 2015691 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    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
    K163381

    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
    Catheter, Oximeter, Fiber-Optic DQE
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    HemoSphere Advanced Monitor (HEM1) Roll Stand (HEMRLSTD1000) HemoSphere Swan-Ganz Module (HEMSGM10) HemoSphere Oximetry Cable (HEMOXSC100)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility