BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    iTFlow

    Reg #: 3029906636 · FEI: 3029906636 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIO FLOW DESIGN INC.
    Registration Number
    3029906636
    FEI Number
    3029906636
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22-3 Ichiban-cho, Chiyoda-ku
    City
    Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K222854

    Owner / Operator

    Firm Name
    Cardio Flow Design Inc.
    Operator Number
    10088423
    Address
    22-3 Ichiban-cho, Chiyoda-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    1020082
    Country
    JP
    Correspondent
    Shohei Miyazaki

    US Agent

    Business Name
    510K Technology Group LLC
    Contact Name
    Kachi Enyinna
    Address
    1337 Mass Ave, #286
    City
    Arlington
    State
    MA
    ZIP
    02476
    Country
    US
    Email
    [email protected]
    Phone
    617 8704055

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    iTFlow

    Establishment Types

    Manufacture Medical Device