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510(k) Data Aggregation

    K Number
    K052767
    Device Name
    AFIBALERT ATRIAL FIBRILLATION DETECTOR
    Manufacturer
    LECHNOLOGIES RESEARCH INC.
    Date Cleared
    2006-06-23

    (266 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    LECHNOLOGIES RESEARCH INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AfibAlert™ is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
    Device Description
    The AfibAlert™ is a cardiac event recorder capable of storing five 45-second events in solid-state non-volatile memory. AfibAlert™ allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke. The device can record a single channel of ECG data in three ways: (1) via the two thumb electrodes, (2) by placement on the chest, or (3) by applying wrist electrodes. In each case, the patient initiates the recording. The recording takes approximately 45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The appropriate LED (light emitting diode) is illuminated to indicate the presence or absence of AF. If AF is indicated, or concerning symptoms are present, the patient makes a telephone call to a service provider as specified by their physician and transmits the ECG data to the receiving personnel. Data can also be transferred by using a computer.
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