Search Results
Found 1 results
510(k) Data Aggregation
K Number
K033543Device Name
NARCOTREND, MODEL COMPACT 4.0
Manufacturer
Date Cleared
2004-09-17
(312 days)
Regulation Number
882.1400Why 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