# Bio-Logic Systems Corp.

- Location (FDA's records): Mudelein, IL
- FDA decisions: 45 (1981–2012): 45 510(k) clearances
- Product codes: EWO (9), GWJ (7), GWQ (5), GWE (4), GWF (3), OLV (3), GXY (2), GWN (2), IKN (2), GWK (2), MNR (2), ETW (1)
- Predicates its devices cite: 27 (19 its own); citations of its devices by later devices: 48 (19 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Natus Medical, Inc.: 3 (https://510kreport.com/company/natus-medical)
- Fischer-Zoth Audiologic Systems, Inc.: 1 (https://510kreport.com/company/fischer-zoth-audiologic-systems)
- Biologic Systems Corp.: 1 (https://510kreport.com/company/biologic-systems)
- Etymotic Research: 1 (https://510kreport.com/company/etymotic-research)
- Otodynamics, Ltd.: 1 (https://510kreport.com/company/otodynamics)
- Pro-Tech, Inc.: 1 (https://510kreport.com/company/pro-tech)

## Firms that cite its devices most
- Natus Medical, Inc.: 9 (https://510kreport.com/company/natus-medical)
- Intelligent Hearing Systems: 3 (https://510kreport.com/company/intelligent-hearing-systems)
- Applied Neuroscience, Inc.: 2 (https://510kreport.com/company/applied-neuroscience)
- Nxlink, Ltd.: 2 (https://510kreport.com/company/nxlink)
- Grass Instrument Co.: 2 (https://510kreport.com/company/grass-instrument)
- Path Medical GmbH: 1 (https://510kreport.com/company/path-medical)
- Ventus Medical, Inc.: 1 (https://510kreport.com/company/ventus-medical)
- Nihon Kohden America, Inc.: 1 (https://510kreport.com/company/nihon-kohden-america)

## Its most-cited devices
- K994149: Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. (1999), cited by 4
- K021895: Bio-Logic Master Evoked Response System (2002), cited by 3
- K974076: Sport/Audx Oae Test Instrument with Bio-Logic Ear Probe (1998), cited by 3
- K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions (2002), cited by 3
- K964132: Modification to Otoacoustic Emissions (OAE0 Test Instrument (1997), cited by 3
- K962103: Bio-Logic Sleepscan Product with Built-in Oximeter (1996), cited by 3

## Recent decisions
- K122496: Audx Pro Otoacoustic Emissions Measurement System (Nov 1, 2012)
- K121512: Scout Sport Otoacoustic Emissions Measurement System (Jul 26, 2012)
- K073626: Bio-Logic Master II Evoked Response System (Feb 5, 2008)
- K061744: Cochlea-Scan / Cochlea-Scan Plus (Sep 15, 2006)
- K052066: Ceegraph/Sleepscan Netlink Traveler (Aug 26, 2005)
- K031352: Bio-Logic Insert Earphones (Jul 16, 2003)
- K030907: Stacked Abr for Navigator Pro (May 9, 2003)
- K031009: Modification to Bio-Logic Evoked Potential (EP) System (Apr 28, 2003)

Source page: https://510kreport.com/company/bio-logic-systems