Bio-Logic Systems Corp.
Medical device manufacturer in Mundelein, IL.
45510(k) clearances
0PMA approvals
2recalls
Device types
- EWO Audiometer 9
- GWJ Stimulator, Auditory, Evoked Response 7
- GWQ Full-Montage Standard Electroencephalograph 5
- GWE Stimulator, Photic, Evoked Response 4
- GWF Stimulator, Electrical, Evoked Response 3
- OLV Standard Polysomnograph With… 3
- GWK Conditioner, Signal, Physiological 2
- GWN Nystagmograph 2
- IKN Electromyograph, Diagnostic 2
- GXY Electrode, Cutaneous 2
- MNR Ventilatory Effort Recorder 2
- ETW Calibrator, Hearing Aid / Earphone And… 1
- BZQ Monitor, Breathing Frequency 1
- OMB Automatic Event Detection Software For… 1
- HCC Device, Biofeedback 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K122496 | Audx Pro Otoacoustic Emissions Measurement SystemEWO · Traditional | 11/01/2012SE |
| K121512 | Scout Sport Otoacoustic Emissions Measurement SystemEWO · Traditional | 07/26/2012SE |
| K073626 | Bio-Logic Master II Evoked Response SystemGWJ · Special | 02/05/2008SE |
| K061744 | Cochlea-Scan / Cochlea-Scan PlusEWO · Traditional | 09/15/2006SE |
| K052066 | Ceegraph/Sleepscan Netlink TravelerOLV · Special | 08/26/2005SE |
| K031352 | Bio-Logic Insert EarphonesEWO · Traditional | 07/16/2003SE |
| K030907 | Stacked Abr for Navigator ProGWJ · Special | 05/09/2003SE |
| K031009 | Modification to Bio-Logic Evoked Potential (Ep) SystemGWJ · Special | 04/28/2003SE |
| K021895 | Bio-Logic Master Evoked Response SystemGWJ · Special | 07/01/2002SE |
| K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsEWO · Special | 06/27/2002SE |
| K021215 | Bio-Logic Abaer CubGWJ · Special | 05/15/2002SE |
| K012384 | Ear MuffinsHCC · Traditional | 10/15/2001SE |
| K003681 | Bio-Logic Sleepscan NetlinkOLV · Special | 12/21/2000SE |
| K002570 | Bio-Logic Ceegraph NetlinkGWQ · Special | 09/14/2000SE |
| K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.GWJ · Special | 12/27/1999SE |
| K992807 | Bio-Logic Evoked Potential for Abaer IGWJ · Special | 09/14/1999SE |
| K983913 | Modification to Bio-Logic SleepscanOLV · Special | 11/25/1998SE |
| K973883 | Bio-Logic Ceegraph 128-CHANNEL Recording SystemGWQ · Traditional | 03/05/1998SE |
| K974076 | Sport/Audx Oae Test Instrument with Bio-Logic Ear ProbeEWO · Traditional | 01/22/1998SE |
| K971501 | Sleepscan Airflow Pressure TransducerMNR · Traditional | 10/14/1997SE |
| K964132 | Modification to Otoacoustic Emissions (OAE0 Test InstrumentEWO · Traditional | 05/13/1997SE |
| K962103 | Bio-Logic Sleepscan Product with Built-In OximeterMNR · Traditional | 08/22/1996SE |
| K961447 | Scout Sport - a Modification to (Formerly Emav) Otoacoustic Emissions (Oae) Test…EWO · Traditional | 05/29/1996SE |
| K954954 | Ceegraph Traveler Ambulatory EEG RecorderGWQ · Traditional | 01/25/1996SE |
| K944314 | Disposable Tm-E Cochgtrode - BLSC Part No. 101123GXY · Traditional | 01/03/1996SE |
| K951594 | Bio-Logic Automatic Event AnalysisOMB · Traditional | 08/22/1995SE |
| K941928 | Various ElectrodesGWN · Traditional | 02/03/1995SE |
| K941799 | Disposable Cutaneous ElectrodesGXY · Traditional | 02/03/1995SE |
| K944735 | Bio-Logic Emav Emission Averaging Otoacoustic TestEWO · Traditional | 12/21/1994SE |
| K933233 | Ceegraph, ModificationGWQ · Traditional | 03/03/1994SE |
| K930790 | Addition of Built-In Oxymeter to Sleepscan Prod.BZQ · Traditional | 01/06/1994SE |
| K930328 | Navigator & Traveler Evoked Postential ProductIKN · Traditional | 07/02/1993SE |
| K893130 | Emg Navigator & Emg TravelerIKN · Traditional | 03/20/1990SE |
| K895125 | CeegraphGWQ · Traditional | 12/22/1989SE |
| K874136 | Photic Stimulator Models 580-PSCOMP,PSCEEG,PSSTALGWE · Traditional | 03/25/1988SE |
| K872290 | Bio-Logic BankerGWK · Traditional | 10/06/1987SE |
| K870337 | AudiometerETW · Traditional | 04/16/1987SE |
| K862690 | Traveler LTGWF · Traditional | 11/25/1986SE |
| K854362 | Modified Brain Atlas IIIGWE · Traditional | 04/22/1986SE |
| K852533 | L.E.D. Goggles, Model 580-LEDGOGGWE · Traditional | 12/12/1985SE |
| K850180 | Electronystagmograph (Eng Recorder)GWN · Traditional | 07/22/1985SE |
| K844992 | Bio-Logic Portable Evoked Response SystemGWF · Traditional | 06/07/1985SE |
| K842543 | Evoked Potential SysGWF · Traditional | 11/29/1984SE |
| K831047 | Biologic System BL 101GWE · Traditional | 05/13/1983SE |
| K803226 | Evoked Response StimulatorsGWK · Traditional | 02/05/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0001-2008 | Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and…Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during… | 07/26/2007Terminated |
| Z-0761-2007 | Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company…Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in… | 02/26/2007Terminated |