# K131789: Cerebralogik- Aeeg

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Ltd.
- Decided: Dec 27, 2013 after 192 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: 5 generations back to K963644 (1996). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031149: Olympic CFM 6000, Olympic Medical Corp. (2003) Summary page 2.

## Most influential descendants
- K130238: Nihon Kohden AE-918P Neuro Unit (2015), 0 descendants of its own

## Indications for use
The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - sEEG and in conjunction with other clinical data.

Source page: https://510kreport.com/device/K131789
Methodology: https://510kreport.com/methodology