# K944735: Bio-Logic Emav Emission Averaging Otoacoustic Test

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Dec 21, 1994 after 86 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K964132: Modification to Otoacoustic Emissions (OAE0 Test Instrument (1997), 4 descendants of its own
- K112247: A Baer with Abaer I/O Function (2012), 1 descendant of its own
- K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function (2011), 1 descendant of its own
- K122496: Audx Pro Otoacoustic Emissions Measurement System (2012), 0 descendants of its own
- K121512: Scout Sport Otoacoustic Emissions Measurement System (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K944735
Methodology: https://510kreport.com/methodology