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510(k) Data Aggregation

    K Number
    K062068
    Device Name
    INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0
    Manufacturer
    INTELWAVE, LLC
    Date Cleared
    2006-10-27

    (98 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTELWAVE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intelwave 1.0 System is intended for use in Heart Rate Variability (HRV) measurements in response to paced respiration and controlled exercises.
    Device Description
    The Intelwave 1.0 System is a computer-based system for measurement of Heart Rate Variability (HRV) in response to paced respiration and controlled exercises. The system performs a fully automated quantitative analysis of HRV based on data collected by an FDA-compliant R Wave Trigger device recommended or supplied by Intelwave. The system presents the results to the physician through a computer-based user interface. The system has patient data management capability.
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