# K973596: Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Feb 3, 1998 after 134 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: 1 generation back to K963644 (1996). 1 ancestor in all.
30 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor, Aspect Medical Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K983229: Olympic Medical Lectromed Cerebral Function Monitor System (1999), 29 descendants of its own
- K030489: BRM2 Brain Monitor (2003), 25 descendants of its own
- K033010: BRM2 Brain Monitor (2003), 23 descendants of its own
- K020335: Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 (2002), 18 descendants of its own
- K031149: Olympic CFM 6000 (2003), 17 descendants of its own

## Indications for use
Patient conditions indicated by abnormalities in electroencephalograph (EEG) signals in the brain. Caution statement is provided in the introductory page of the Patient Care Information System which includes the operating instructions for this Module. Electrodes connected to the Module are applied externally to the scalp. Frequency as directed by physician. To monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room anc for clinical resaarch, and To display a Bispectral Index (BIS), a processed EEG variable, which may be used as an aid in monitoring the effects of certain anesthetic agents.

Source page: https://510kreport.com/device/K973596
Methodology: https://510kreport.com/methodology