BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Stealth System S300

    Reg #: 3014848734 · FEI: 3014848734 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DREAMTECH CO., LTD.
    Registration Number
    3014848734
    FEI Number
    3014848734
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    161, Asanbaelli-Ro 388 Beon-Gil, Eumbong-Myeon
    City
    Asan-si Chungnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K162503

    Owner / Operator

    Firm Name
    Dreamtech co., ltd.
    Operator Number
    10058403
    Address
    670 Daewangpangyo-ro, Bundang-gu
    City
    Seongnam-si
    State
    Gyeonggi
    Postal Code
    13494
    Country
    KR
    Correspondent
    Donghwan Kim

    US Agent

    Business Name
    LifeSignals, Inc.
    Contact Name
    Saravanan Balasubramanian
    Address
    426 South Hillview Drive
    City
    Milpitas
    State
    CA
    ZIP
    95035
    Country
    US
    Email
    [email protected]
    Phone
    510 7706412 ext. 4

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Recorder, Magnetic Tape, Medical DSH

    Proprietary Names

    Stealth System S300

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)