# K994149: Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: Dec 27, 1999 after 19 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: 2 generations back to K930328 (1993). 2 ancestors in all.
21 later devices descend from it; 4 cite 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)
- K992807: Bio-Logic Evoked Potential for Abaer I, Bio-Logic Systems Corp. (1999) Summary page 1.

## Most influential descendants
- 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
- K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions (2002), 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 feature modifications represented in this Special 510(k) are for the use of a redesigned hardware package and a Windows- based software program to control the hardware. The functions and electronic design of the hardware are substantially the same as those of the Predicate Device hardware. The software for control of this device is a simplified subset of the DOS-based Predicate Device software. Together, they implement the same infant hearing screening functions and perform the same intended use as the Predicate Device, but with improved ease-of-use. The POVR algorithm described in the Predicate Device is implemented in the new Windows software 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, 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/K994149
Methodology: https://510kreport.com/methodology