# K060900: Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories Model-91842

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Jun 23, 2006 after 81 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K071899: Bis Module for Envoy Patient Monitor (2007), 1 descendant of its own
- K083063: Bis Interface for Vitalogik Patient Monitors (2008), 0 descendants of its own

## Indications for use
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

Source page: https://510kreport.com/device/K060900
Methodology: https://510kreport.com/methodology