BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OxiWear

    Reg #: 3026998289 · FEI: 3026998289 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    OXIWEAR INC
    Registration Number
    3026998289
    FEI Number
    3026998289
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2231 Crystal Dr Ste 204
    City
    Arlington
    State
    VA
    ZIP
    22202
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233827

    Owner / Operator

    Firm Name
    OxiWear Inc
    Operator Number
    10092245
    Address
    2231 Crystal Dr, Ste 204
    City
    Arlington
    State
    VA
    Postal Code
    22202
    Country
    US
    Correspondent
    Shavini Fernando

    Products

    Device Name Product Code
    Oximeter, Ear DPZ
    Oximeter DQA

    Proprietary Names

    OxiWear

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device