# K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Oct 8, 1996 after 26 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.
340 later devices descend from it; 5 cite it directly.
0 of 341 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
- K974496: A-2000 Eeg Monitor with Bis (1998), 337 descendants of its own
- K012466: Bis/Eeg Module (2001), 305 descendants of its own
- K031694: Modification to Eeg Monitor with Bis, Model a-2000 (2003), 304 descendants of its own
- K030267: Eeg Monitor with Bis, Model a-2000 (2004), 303 descendants of its own
- K040183: BISX (2004), 274 descendants of its own

## Indications for use
The Aspect EEG Monitors with BIS are intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research. The Bispectral Index (BIS), a processed EEG varisble, may be used as an aid in monitoring the effects of certain anesthetic agents.

Source page: https://510kreport.com/device/K963644
Methodology: https://510kreport.com/methodology