BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QT MEDICAL, INC

    Reg #: 3013684844 · FEI: 3013684844 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    QT MEDICAL, INC
    Registration Number
    3013684844
    FEI Number
    3013684844
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1370 Valley Vista Drive, Suite 266
    City
    Diamond Bar
    State
    CA
    ZIP
    91765
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233521

    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
    Yu-Ting Chen

    Products

    Device Name Product Code
    Electrode, Electrocardiograph DRX
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Cable, Electrode IKD

    Proprietary Names

    PCA 500 PCA 500+ QT ECG 12-Lead Electrocardiograph ECG Recorder (PCA 300) PCA-C100BS AHA Patient Cable PCA-C100 AHA Patient Cable PCA-C100BL AHA Patient Cable PCA-C101BS IEC Patient Cable PCA-C101BL IEC Patient Cable PCA-C101 IEC Patient Cable QT ECG Disposable Electrode Strip (QHeart Sensor) Size XL QT ECG Disposable Electrode Strip (QHeart Sensor) Size S QT ECG Disposable Electrode Strip (QHeart Sensor) Size L QT ECG Disposable Electrode Strip (QHeart Sensor) Size M QT ECG EM Electrode Strip Size S QT ECG Disposable Electrode Strip (QHeart Sensor) Size 3 QT ECG Disposable Electrode Strip (QHeart Sensor) Size 2 QT ECG Disposable Electrode Strip (QHeart Sensor) Size 1 QT ECG EM Electrode Strip Size XL QT ECG EM Electrode Strip Size M QT ECG EM Electrode Strip Size L QT ECG (QHeart SENSOR) Size 0 QT ECG Disposable Electrode Strip (QHeart Sensor) Size F PCA-A110 QHeart Cable Z PCA-A210 QHeart Cable Z PCA-A200 Electrode Cable PCA-A400 Extension Cable PCA-A120 S QHeart Cable GS PCA-A300 ECG Cable Converter PCA-A130 QHeart Cable P PCA-A120 L QHeart Cable GL PCA-A100 QHeart Cable L

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device