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510(k) Data Aggregation

    K Number
    K090037
    Device Name
    MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
    Manufacturer
    MEDICALGORITHMICS SP Z.O.O.
    Date Cleared
    2009-05-22

    (136 days)

    Product Code
    DSI, MLO
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICALGORITHMICS SP Z.O.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use for the PocketECG monitor are as follows: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter. 8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes.
    Device Description
    PocketECG - Medicalgorithmics Real-Time ECG Monitor and Arrhythmia Detector is an ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beat and ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff. The data transmission is automatically triggered when abnormalities are detected, or periodically in case of normal ECG. The patient worn transmitter streams via Bluetooth link the ECG signal to a Windows Mobile operated PDA (Personal Digital Assistant) device with mobile phone capabilities. The PDA runs Medicalgorithmics proprietary software which detects the ECG annotations and manages the data transmission. The PDA device stores entire ECG on its storage card.
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