BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MDL2122A

    Reg #: 1000207387 · FEI: 1000207387 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    JVCKENWOOD Corporation
    Registration Number
    1000207387
    FEI Number
    1000207387
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-12, Moriya-cho, Kanagawa-ku
    City
    Yokohama-shi Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K070370

    Owner / Operator

    Firm Name
    JVCKENWOOD Corporation
    Operator Number
    10044588
    Address
    3-12, Moriya-cho, Kanagawa-ku,
    City
    Yokohama-shi,
    State
    Kanagawa
    Postal Code
    221-0022
    Country
    JP

    US Agent

    Business Name
    JVCKENWOOD USA Corporation
    Contact Name
    Angie Seay
    Address
    1440 Corporate Drive, Irving, TX 75038
    City
    Irving
    State
    TX
    ZIP
    75038
    Country
    US
    Email
    [email protected]
    Phone
    678 4498879

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    MDL2122A

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198