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510(k) Data Aggregation

    K Number
    K123472
    Device Name
    CIMVA UNIVERSAL
    Date Cleared
    2013-03-05

    (112 days)

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

    THERAPEUTIC MONITORING SYSTEMS (TMS), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CIMVA Universal is indicated for analyzing patterns of variation of physiological parameters (heart rate and respiratory rate) derived from the output of third party monitoring systems. CIMVA Universal is not designed for vital signs monitoring or self-monitoring of patients.
    Device Description
    The CIMVA Universal software is resident in a hospital server or other computer that is periodically connected to a repository of recorded data from third party physiological monitors. The current version of the software has four functions: 1. Allows the user to import a specified amount of recorded monitor data (e.g. up to 96 hours) stored in external repositories. 2. Allows the physician to choose the type of multi-organ variability analysis that he/she desires. 3. Calculates the selected measures of Variability. 4. Provides a physician-configurable report of the calculations CIMVA Universal also allows the clinician to measure the degree to which multi-organ variability measures are altered in response to clinical events that are input by the user. The calculations performed by CIMVA Universal are algorithms available in the public domain (as described in journal articles, etc.). None of the variability measures are proprietary to TMS. The results of these analyses could help physicians conduct research on the potential clinical utility of one or more of these variability measurements.
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