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510(k) Data Aggregation

    K Number
    K072385
    Device Name
    HEARTEVENT, MODEL AT
    Date Cleared
    2008-01-11

    (140 days)

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

    DIAGNOSTIC DEVICES PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The heartEVENT^T is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.
    Device Description
    The heartEVENT* is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms. The transmission of these recordings is by telephone to a receiving system. The heartEVENTAT has two operating modes – manual and automatic trigger. In the manual mode, the heartEVENT^T stores the ECG before and after the 'record' button is depressed. The recording period is preset up to 80 seconds with 2 manually activated recordings stored. The heartEVENTAT also has an automatic triggering function where recording is automatically activated when the user experiences a cardiac symptom. Cardiac symptoms captured by the auto-trigger function include bradycardia, pause and atrial fibrillation. The heartEVENT^T is configured with 'pre' and 'post' event memories with a total ECG recording time for up to 320 sec. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the heartEVENTAT by manually depressing the 'send' button.
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