BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    O3 Sensor

    Reg #: 3004415095 · FEI: 3004415095 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Industrial Vallera de Mexicali, S. A. de C. V.
    Registration Number
    3004415095
    FEI Number
    3004415095
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calzada del Oro no. 2001, Parque Industrial Palaco
    City
    Mexicali Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K214072

    Owner / Operator

    Firm Name
    MASIMO CORPORATION
    Operator Number
    9031881
    Address
    52 Discovery, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Oximeter, Tissue Saturation MUD

    Proprietary Names

    O3 Sensor O3 Regional Oximetry

    Establishment Types

    Manufacture Medical Device