# K030907: Stacked Abr for Navigator Pro

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: May 9, 2003 after 46 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: 3 generations back to K930328 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994149: Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro., Bio-Logic Systems Corp. (1999) 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 Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing-related disorders. Auditory stimuli are presented to the patient's ear through an earphone or headphones, and the corresponding Auditory Brainstem Responses (ABR) from the patient are recorded using EEG electrodes placed on the scalp. Standard ABR testing is most used clinically for 2 reasons: (I)to predict behavioral audiometric thresholds, and (2) as an audiological testing tool to assist in the assessment of possible auditory nervous system abnormalities. The Bio-logic Navigator Pro EP System can be used for patients of all ages, from children to adults, including infants and geriatric patients. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional.

Source page: https://510kreport.com/device/K030907
Methodology: https://510kreport.com/methodology