# K033543: Narcotrend, Model Compact 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Mt Monitortechnik GmbH & Co. KG
- Decided: Sep 17, 2004 after 312 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963644 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974496: A-2000 Eeg Monitor with Bis, Aspect Medical Systems, Inc. (1998) Summary page 1.

## Indications for 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.

Source page: https://510kreport.com/device/K033543
Methodology: https://510kreport.com/methodology