BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ECG Recorder (PCA 300)

    Reg #: 3014982325 · FEI: 3014982325 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    QT Medical, INC. Taiwan Branch
    Registration Number
    3014982325
    FEI Number
    3014982325
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14F.-8, No. 2, Jian 8th Rd., Zhonghe Dist.
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K220795

    Owner / Operator

    Firm Name
    QT MEDICAL, INC
    Operator Number
    10058094
    Address
    1370 Valley Vista Drive, Suite 266
    City
    Diamond Bar
    State
    CA
    Postal Code
    91765
    Country
    US
    Correspondent
    Ying-lung Cheng

    US Agent

    Business Name
    QT MEDICAL, INC
    Contact Name
    Ying-lung Cheng
    Address
    1370 Valley Vista Drive, Suite 266
    City
    Diamond Bar
    State
    CA
    ZIP
    91765
    Country
    US
    Email
    [email protected]
    Phone
    424 5583500

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    ECG Recorder (PCA 300) QT ECG 12-Lead Electrocardiograph PCA 500

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198