BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ECG Recorder (PCA 300)

    Reg #: 3013684844 · FEI: 3013684844 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QT MEDICAL, INC
    Registration Number
    3013684844
    FEI Number
    3013684844
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1370 Valley Vista Drive, Suite 266
    City
    Diamond Bar
    State
    CA
    ZIP
    91765
    Country
    US

    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

    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

    Complaint File Establishment per 21 CFR 820.198