# K973883: Bio-Logic Ceegraph 128-Channel Recording System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Mar 5, 1998 after 142 days
- Product code: GWQ (Full-Montage Standard 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: 1 generation back to K933233 (1994). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933233: Ceegraph, Modification, Bio-Logic Systems Corp. (1994) Summary page 1.

## Most influential descendants
- K994142: Grass TS3201/6401 Eeg Amplifier System (2000), 6 descendants of its own
- K050425: Aura-PSG (2005), 5 descendants of its own
- K071782: Micromed Brain Spy Plus, Embia Titanium Devices (2008), 4 descendants of its own
- K012079: Geodesic Eeg System, Model 200 (2001), 4 descendants of its own
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family (2013), 3 descendants of its own

## Indications for use
The Bio-logic Ceegraph family is indicated for use in the recording and analysis of routine EEG tests. Typical EEG tests are 20-30 minutes in duration. but the Ceegraph system can also be used for longer tests. including continuous long-term EEG monitoring with patient video. EEG testing is indicated for use whenever it is necessary to measure and record the electrical activity of a patient’s brain by attaching multiple electrodes at various locations on the scalp. The 128 Channel Data Recording system has a similar intended use to that of the 32 channel Ceegraph recording system. It can be used for patients of all ages. from newborn infants through aduits. to and including geriatric patients.

Source page: https://510kreport.com/device/K973883
Methodology: https://510kreport.com/methodology