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510(k) Data Aggregation

    K Number
    K101969
    Device Name
    MH1 MICROHOLTER RECORDER
    Manufacturer
    Date Cleared
    2011-02-04

    (206 days)

    Product Code
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXELYS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MH1 MicroHolter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the following indications: - Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. - Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. - Evaluation of patients for ST segment changes. - Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery). - Clinical and epidemiological research studies. - Evaluation of patients with pacemakers. - Indication of time and frequency domain heart rate variability. - Evaluation of patient for QT interval.
    Device Description
    The MH1 MicroHolter Recorder is a Holter recorder for ambulatory electrocardiogram (ECG) recording. The system consists of three components: a Recorder, a Base Station (computer interface) and the Base Software. The system operates like a conventional ECG monitoring system where data is recorded on Flash memory installed within the MH1 Recorder. The MH1 MicroHolter Recorder is worn by the patient during ECG monitoring whereas the Base Station is connected to a computer. After the recording is complete, the MH1 MicroHolter Recorder docks with the Base Station, connected to a personal computer via USB. The Flash memory is then automatically uploaded to the computer via the MH1 Base Software for basic analysis. Data can then be transferred to a Computer Analysis System for further analysis of the recorded ECG data. The MH1, MH1B Base Station and MH1 Base Software are compatible with Windows 98 or higher. The MicroHolter Recorder system is primarily a 3 channel recorder designed to be as small and lightweight as possible, using a second hardware component, the Base Station, for data interface with a host computer and contact-less monitoring of the recorded signals for electrode placement purposes. The recorder converts the three differential inputs into 10 bit digital values which are stored in an internal FLASH memory along with the condition of the annotate button and a parity check bit. Simultaneously, the data values are modulated onto a low frequency carrier signal which is applied to a magnetic loop antenna so that the signal may be picked up at a short distance and converted into a visible waveform on a host computer for verification of electrode lead function.
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