BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Samsung ECG App v1.3 (ECG)

    Reg #: 3017616353 · FEI: 3017616353 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Samsung Electronics Co., Ltd. Mobile eXperience Business
    Registration Number
    3017616353
    FEI Number
    3017616353
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    129, Samsung-ro, Yeongtong-gu
    City
    Suwon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K240909

    Owner / Operator

    Firm Name
    Samsung Electronics Co., Ltd.
    Operator Number
    10076996
    Address
    129, Samsung-ro, Yeongtong-gu
    City
    Suwon-si
    State
    Gyeonggi
    Postal Code
    16677
    Country
    KR
    Correspondent
    Richard Chon

    US Agent

    Business Name
    Samsung Research America
    Contact Name
    Matthew Wiggins
    Address
    665 CLYDE AVE
    City
    Mountain View
    State
    CA
    ZIP
    94043
    Country
    US
    Email
    [email protected]
    Phone
    650 7705804

    Products

    Device Name Product Code
    Photoplethysmograph Analysis Software For Over-The-Counter Use QDB
    Electrocardiograph Software For Over-The-Counter Use QDA

    Proprietary Names

    Samsung ECG App v1.3 (ECG)

    Establishment Types

    Manufacture Medical Device