# K073626: Bio-Logic Master II Evoked Response System

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: Feb 5, 2008 after 41 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930328 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021895: Bio-Logic Master Evoked Response System, Bio-Logic Systems Corp. (2002) Summary page 1.

## Most influential descendants
- K083371: Navigator Pro with Aep Software (Biomark, Enog, Champ) (2009), 0 descendants of its own

## Indications for use
The Master II Evoked Response System is intended for the recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.

Source page: https://510kreport.com/device/K073626
Methodology: https://510kreport.com/methodology