# K992807: Bio-Logic Evoked Potential for Abaer I

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: Sep 14, 1999 after 25 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: 1 generation back to K930328 (1993). 1 ancestor in all.
22 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930328: Navigator & Traveler Evoked Postential Product, Bio-Logic Systems Corp. (1993) Summary page 1.

## Most influential descendants
- K994149: Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. (1999), 21 descendants of its own
- K021895: Bio-Logic Master Evoked Response System (2002), 13 descendants of its own
- K070696: Interacoustics Assr, Eclipse System (Cabinet Name) (2007), 6 descendants of its own
- K021215: Bio-Logic Abaer Cub (2002), 5 descendants of its own
- K133012: Sentiero (2014), 4 descendants of its own

## Indications for use
The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. An auditory stimulus (click, tone, etc.) is presented to the patient’s ear through an earphone or headphones, and the Brainstem Auditory Evoked Response from the patient is recorded using EEG electrodes placed on the scalp. Although this Brainstem Response is very low in amplitude (with respect to surrounding EEG “noise”), the stimulus-response cycle is repeated many times and the resulting responses are averaged from the time of the stimuli. The random noise averages to zero, but if the Brainstem Response signal is present, it’s signal will be easily determined in the averaged signal. The Bio-logic EP System can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. 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. The primary feature modification represented in this Special 510(k) is for the use of a new algorithm and protocol to generally assist in test data interpretation, and specifically assist in the assessment of signal-to-noise ratio and the quality of the Brainstem Auditory Evoked Response in infants. Based on this automatic assessment, the speed of testing may be reduced and/or the quality of the data recording may be improved. This new feature is used in conjunction with the current EP program, without compromising the quality of recorded data or limiting the control and flexibility of the health care professional administering the test.

Source page: https://510kreport.com/device/K992807
Methodology: https://510kreport.com/methodology