BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OWO IMAGING LLC

    Reg #: 3042864600 · FEI: 3042864600 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    OWO IMAGING LLC
    Registration Number
    3042864600
    FEI Number
    3042864600
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    13820 Sw 139th Ct
    City
    Miami
    State
    FL
    ZIP
    33186
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230800

    Owner / Operator

    Firm Name
    OwO Imaging LLC
    Operator Number
    10095087
    Address
    13820 SW 139th Ct
    City
    Miami
    State
    FL
    Postal Code
    33186
    Country
    US
    Correspondent
    Saul M. Galan Antela

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR

    Proprietary Names

    XVISION-525 Stationary X-ray System

    Establishment Types

    Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device