BEUDAMED
    FDA Registration Active 🇺🇸 United States

    T.Ox

    Reg #: 3009906207 · FEI: 3009906207 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DUKE EMPIRICAL INC.
    Registration Number
    3009906207
    FEI Number
    3009906207
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18705 Madrone Pkwy, Suite 150
    City
    Morgan Hill
    State
    CA
    ZIP
    95037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042657

    Owner / Operator

    Firm Name
    Duke Empirical Inc.
    Operator Number
    10042164
    Address
    18705 Madrone Pkwy, Suite 150
    City
    Morgan Hill
    State
    CA
    Postal Code
    95037
    Country
    US
    Correspondent
    Robert LaDuca

    Products

    Device Name Product Code
    Oximeter, Tissue Saturation MUD

    Proprietary Names

    T.Ox

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)