BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RD SET Disposable sensors

    Reg #: 3019388613 · FEI: 3019388613 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Masimo Corporation
    Registration Number
    3019388613
    FEI Number
    3019388613
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15750 Alton Parkway
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180046

    Owner / Operator

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

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    RD SET Disposable sensors RD SET Multisite Reusable sensors RD SET Reusable sensors RD Speciality sensors

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198