BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intra.Ox 2 Handheld Tissue Oximeter

    Reg #: 3003965364 · FEI: 3003965364 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VIOPTIX, INC.
    Registration Number
    3003965364
    FEI Number
    3003965364
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    39655 Eureka Dr
    City
    Newark
    State
    CA
    ZIP
    94560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221010

    Owner / Operator

    Firm Name
    VIOPTIX, INC.
    Operator Number
    9051676
    Address
    39655 Eureka Drive, --
    City
    Newark
    State
    CA
    Postal Code
    94560
    Country
    US

    Products

    Device Name Product Code
    Oximeter, Tissue Saturation MUD

    Proprietary Names

    Intra.Ox 2 Handheld Tissue Oximeter

    Establishment Types

    Manufacture Medical Device