BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rad-8

    Reg #: 3009601726 · FEI: 3009601726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Masimo Corporation
    Registration Number
    3009601726
    FEI Number
    3009601726
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25 Sagamore Park Road
    City
    Hudson
    State
    NH
    ZIP
    03051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053269

    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

    Rad-8 Masimo SET LNCS reusable sensors Masimo SET LNCS disposable sensors

    Establishment Types

    Repack or Relabel Medical Device