# K042315: Cerebral State Monitor - CSM

- Pathway: 510(k) (Traditional)
- Applicant: Danmeter A/S
- Decided: Jan 21, 2005 after 148 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010965: A-Line Aep Monitor, Alaris Medical Systems, Inc. (2001). Our OCR of the scanned summary read K010865, FDA’s number for Amsco Century Medium Sterilizer, Model Century (STERIS Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AEP Monitor”.
- K974496: A-2000 Eeg Monitor with Bis, Aspect Medical Systems, Inc. (1998) Summary page 1.

## Indications for use
The CSM monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital.

Source page: https://510kreport.com/device/K042315
Methodology: https://510kreport.com/methodology