Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033543
    Device Name
    NARCOTREND, MODEL COMPACT 4.0
    Date Cleared
    2004-09-17

    (312 days)

    Product Code
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MT MONITORTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EEG monitor Narcotrend serves the purpose of registering and displaying EEG signals and thus monitoring the state of the brain. It was developed specifically for use in operating rooms, intensive care units, and for clinical research. The Narcotrend includes the Narcotrend Index, a processed EEG parameter which may be used as an aid in monitoring the effects of certain anesthetic agents.
    Device Description
    The Narcotrend is a stand-alone EEG monitor including the following components: Preamplifier, Monitor for data analysis and display, System lead (connects preamplifier and monitor), Patient lead (connects the electrodes with the preamplifier). The Narcotrend records and processes data of one or two channels of EEG. The monitor display includes the following: Raw EEG, Power spectrum, Processed EEG parameters including spectral parameters, EEG stage, and the Narcotrend Index (current values and trend plots).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1