BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSI OPTOELECTRONICS (MEDICAL DIVISION)

    Reg #: 3006713849 · FEI: 3006713849 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OSI OPTOELECTRONICS (MEDICAL DIVISION)
    Registration Number
    3006713849
    FEI Number
    3006713849
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12525 Chadron Ave
    City
    Hawthorne
    State
    CA
    ZIP
    90250
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083787

    Owner / Operator

    Firm Name
    OSI Optoelectronics (Medical Division)
    Operator Number
    10024288
    Address
    12525 Chadron Ave
    City
    Hawthorne
    State
    CA
    Postal Code
    90250
    Country
    US
    Correspondent
    Kevin Jardim

    Products

    Device Name Product Code
    Oximeter, Ear DPZ
    Oximeter DQA

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)