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510(k) Data Aggregation

    K Number
    K131572
    Device Name
    MICRO AMBULATORY ECG RECORDER
    Date Cleared
    2013-07-22

    (52 days)

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

    DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dimetek Micro Ambulatory ECG Recorder is intended for ECG detecting, recording and playback by adult patients who are concerned about their heart rhythm. It is used both in the clinics and home care environment. User can choose the monitor mode and event mode to record the ECG data when feeling any heart condition occur. The device allows user to record their ECG data in TF card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia. The ECG data in TF card can be downloaded to PC, and be read by ECG viewer software. The device is NOT designed or intended for medical diagnosis.
    Device Description
    The recorder is a handhold, light weight, battery-operated physiological device designed for recording ECG data. For its small size, it may be used in a clinical or non-clinical setting to record physiological signal waveforms while the patient is unattended; the device provides Real-time display function. The device has a resolution of 24-bits with a fundamental sampling frequency of 100, 200, or 400 SPS and is stored un-compressed on a removable TF card. The sampling rate, display rate, display amplitude could be defined through control interface; meanwhile, heart rate would also be measured. The Micro Ambulatory ECG Recorder is used for self-testing before diagnosis and is not recommended for users with implanted pacemakers or defibrillators. It works with a single lead, and has 4 testing modes: - a) Hand contact mode, place your left and right index fingers are touching the touc pads integrated on the device. - b) Leg contact mode, place your index finger on one electrode of the device and place your leg on the other electrode. - c) Chest contact mode, place your right index finger on the right touch pad of and place left touch pad on your chest. - d) Leadwire mode, using leadwires and two disposable electrodes. Paste the disposable electrodes on your body and connect them to the device through the lead wire cable. The measurement data can be stored in the TF card, and then you can download to PC, and read the ECG by ECG Viewer software. The device is NOT designed or intended for medical diagnosis.
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