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510(k) Data Aggregation

    K Number
    K102111
    Device Name
    MEDICAL MAGNETIC TAPE RECORDER
    Manufacturer
    Date Cleared
    2010-12-07

    (132 days)

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

    WPR MEDICAL AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Curvus Sensor - Recorder: Curvus Regular Holter is intended to record single lead (channel) surface ECG data and accelerometer data from ambulatory patients (Holter) for a period of up to 72 hours (3 days). Recorded ECG data are intended to be analyzed by Curvus Analyzer. The Sensor and Recorder are intended for use outside of the hospital. Curvus software suite: Curvus Examiner is intended to program set up and closure of examination, while Curvus Analyzer analyzes the retrieved data from the examination. The system is intended to be used by trained operators under the direct supervision of a trained Health Care Practitioner in a hospital or a clinic environment.
    Device Description
    The Curvus Regular Holter System is a wireless mobile system for collecting a 1-lead electrocardiogram from a patient and to present the results to medical personnel such as cardiologists with the purpose to assist them to diagnose arrhythmias (heart rhythm irregularities). The Curvus Regular Holter System consists of a set of functional units including software: - Curvus ECG Sensor to be applied to the patient's chest to measure ECG signal . - Curvus ECG Recorder a hand-held device to store monitored data . - Curvus ECG Examiner and Curvus ECG Analyzer software programs to be used by . medical staff for setup and closure of patient examination and for diagnostic evaluation.
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