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510(k) Data Aggregation

    K Number
    K152135
    Device Name
    Quantitative Electrocardiographic Detector (QED 2000)
    Date Cleared
    2016-08-09

    (375 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACME Portable Machines, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended Use: The intended use of the QED2000 is to record 12-lead ECG signals from patient's heart activity through body surface ECG electrodes. This device can acquire, display, record, analyze, and store these ECG signals from adult patients for review by the user. Analysis of the ECG signals is accomplished with algorithms that provide data presentations, graphical presentations, and measurements. These are presented for review and interpretation by a trained physician or clinician in determining a diagnosis based upon knowledge of the result of physical examination, and other clinical findings. The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals. Indications for Use: The QED2000 is intended to be used to acquire, display, record, analyze, and store 12-lead ECG waveforms from adult patients through body surface ECG electrodes. Using algorithms to generate data presentations, graphical presentations, and measurements for review and interpretation by a trained physician in determining a diagnosis based upon knowledge of the patient, the result of physical examination, and other relevant clinical findings. The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals. The QED2000 is not intended to be used as a cardiac monitor.
    Device Description
    The Quantitative Electrocardiographic Detector (QED2000) is a 12-lead resting electrocardiograph. It is a device for acquiring, displaying, analyzing and storing the 12-lead electrocardiogram. The device can print the resting ECG report via the external printer including USB printer and network printer. The device has optional removable storage to store resting ECG records. The device also can export the resting ECG record to SD card/shared directory/FTP server as an optional function. An optional USB barcode reader and magnetic card scanner to enter patient information is also available.
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