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510(k) Data Aggregation

    K Number
    K021230
    Device Name
    HERO
    Manufacturer
    MEDICAL DECISION NETWORKS
    Date Cleared
    2003-05-09

    (386 days)

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

    MEDICAL DECISION NETWORKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HERO is intended to acquire, store, analyze, and report on ECG data collected from infants. HERO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment. HERO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HERO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate. HERO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The specialized HRV measurements produced by HERO have not been approved by the FDA for any specific clinical diagnosis. HERO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.
    Device Description
    HERO is comprised of several off-the-shelf Personal Computers (PC's) capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring real-time network. Data is acquired, stored, analyzed, and displayed on a Bedside Monitoring Station (BMS) located near each patient. Demographic data is entered on a Central Monitoring Station (CMS). Results of the analyses are reported by both the CMS and the BMS. The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.
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