BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    ISA CO2

    Reg #: 3005135175 · FEI: 3005135175 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IV FROHE Sweden AB
    Registration Number
    3005135175
    FEI Number
    3005135175
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    STROMFALLSVAGEN 4
    City
    Tyreso Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K103604

    Owner / Operator

    Firm Name
    Masimo Corporation
    Operator Number
    9075000
    Address
    52 Discovery
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Mathew - Jimenez

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK

    Proprietary Names

    ISA CO2 ISA OR+ ISA AX+

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)