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510(k) Data Aggregation

    K Number
    K101983
    Device Name
    CRITICAL CARE ASSESSMENT
    Manufacturer
    CRITICAL PATIENT CARE, INC.
    Date Cleared
    2010-09-21

    (69 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRITICAL PATIENT CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    'Critical Care Assessment' is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
    Device Description
    Critical Care Assessment device is a microprocessor based, monitor biomedical acquisition system - it identifies, classifies, and collects ECG and Plethysmograph signals from the human body. The analog signals are converted to digital data and transferred to the personal computer via isolated USB connection. This isolation separates the human body from the main power system to ensure maximum patient safety. The patient data collected from the unit is used to perform Heart Rath Variability Analysis and obtain several detailed assessment of the Autonomic Function (Autonomic Nervous System Balance), Blood flow, Stress, Fitness and the overall health risk analysis.
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