# K983229: Olympic Medical Lectromed Cerebral Function Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Olympic Medical Corp.
- Decided: Mar 23, 1999 after 189 days
- Product code: OMA (Amplitude-Integrated Electroencephalograph)
- 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.
29 later devices descend from it; 4 cite it directly.
0 of 33 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.
- K973596: Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module, Spacelabs Medical, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K071449: BRM3 Brain Monitor (2007), 15 descendants of its own

## Indications for use
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.

Source page: https://510kreport.com/device/K983229
Methodology: https://510kreport.com/methodology