FDA 510(k) Applications for Medical Device Product Code "GWJ"
(Stimulator, Auditory, Evoked Response)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K021215 | BIO-LOGIC SYSTEMS CORP. | BIO-LOGIC ABAER CUB | 05/15/2002 |
| K992807 | BIO-LOGIC SYSTEMS CORP. | BIO-LOGIC EVOKED POTENTIAL FOR ABAER I | 09/14/1999 |
| K021895 | BIO-LOGIC SYSTEMS CORP. | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM | 07/01/2002 |
| K073626 | BIO-LOGIC SYSTEMS CORP. | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | 02/05/2008 |
| K031009 | BIO-LOGIC SYSTEMS CORP. | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | 04/28/2003 |
| K994149 | BIO-LOGIC SYSTEMS CORP. | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. | 12/27/1999 |
| K030907 | BIO-LOGIC SYSTEMS CORP. | STACKED ABR FOR NAVIGATOR PRO | 05/09/2003 |
| K972157 | EXCEL TECH. LTD. | EXCEL AV STIM 1000 | 01/30/1998 |
| K013977 | FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. | ECHO-SCREEN T, TA, TD, TDA, TC | 06/14/2002 |
| K123701 | FRYE ELECTRONICS, INC. | HEARLAB ACA | 04/05/2013 |
| K092373 | GN OTOMETRICS | ICS CHARTR EP 200 | 09/03/2009 |
| K132957 | GN OTOMETRICS | MADSEN ACCUSCREEN TYPE 1077 | 02/27/2014 |
| K122067 | GN OTOMETRICS | TYPE 1077 ACCUSCREEN | 09/27/2012 |
| K083399 | GN OTOMETRICS A/S | ICS CHARTR EP 200 | 02/20/2009 |
| K143670 | GN OTOMETRICS A/S | ICS CHARTR EP 200 WITH VEMP | 10/23/2015 |
| K193033 | Grason Stadler | GSI Audera Pro | 04/24/2020 |
| K960097 | ICS MEDICAL CORP. | CHARTR EP | 02/21/1997 |
| K002985 | ICS MEDICAL CORP. | ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS | 12/13/2000 |
| K991853 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) | INTERACOUSTICS EP 15 ABR STAND ALONE UNIT | 10/25/1999 |
| K073384 | INTELLIGENT HEARING SYSTEMS | SMART COUPLER, MODEL M015401 | 02/28/2008 |
| K061443 | INTELLIGENT HEARING SYSTEMS | SMART USBLITE, MODEL M011120 | 06/23/2006 |
| K163326 | INTELLIGENT HEARING SYSTEMS | SmartEP | 09/29/2017 |
| K031051 | INTELLIGENT HEARING SYSTEMS | SMARTEP-ASSR, MODEL M811007 | 02/20/2004 |
| K070608 | INTELLIGENT HEARING SYSTEMS | SMARTEP, MODEL M010000 | 07/18/2007 |
| K090579 | INTELLIGENT HEARING SYSTEMS | SMARTSCREENER-PLUS2 | 07/07/2009 |
| K162037 | INTERACOUSTICS A/S | Eclipse with VEMP | 03/23/2017 |
| K070696 | INTERACOUSTICS A/S | INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) | 06/29/2007 |
| K103760 | INTERACOUSTICS A/S | TITAN | 05/05/2011 |
| K011746 | MAICO DIAGNOSTIC GMBH | MB 11 | 08/24/2001 |
| K082035 | MAICO DIAGNOSTICS | MAICO MB 11 WITH BERAPHONE PROBE | 01/29/2009 |
| K141446 | NATUS MEDICAL INCORPORATED | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | 08/22/2014 |
| K233649 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | ALGO Pro Newborn Hearing Screener (ALGO Pro) | 03/08/2024 |
| K013137 | NATUS MEDICAL, INC. | ALGO 3 NEWBORN HEARING SCREENER | 10/16/2001 |
| K030823 | NATUS MEDICAL, INC. | ALGO 3I NEWBORN HEARING SCREENER | 04/09/2003 |
| K073665 | NATUS MEDICAL, INC. | ALGO 5 NEWBORN HEARING SCREENER | 01/25/2008 |
| K211147 | Path Medical GmbH | ALGO 7i | 10/14/2021 |
| K100661 | PATH MEDICAL GMBH | EARPROBE | 07/01/2010 |
| K131141 | PATH MEDICAL GMBH | EARPROBE | 06/27/2013 |
| K220139 | PATH MEDICAL GmbH | QScreen | 08/03/2022 |
| K111555 | R & D MEDICAL PRODUCTS, INC. | CIRCUMAURAL ADHESIVE REPLACEMENT | 07/25/2011 |
| K993177 | SLE LIMITED | SABRE | 11/16/1999 |
| K011842 | SLE LIMITED | SABRE COMPAC | 01/08/2002 |
| K012415 | SYNAPSYS, INC. | AURIS AEP | 12/18/2001 |
| K242954 | Vivosonic Inc | Integrity V500 (Integrity, Integrity with VEMP) | 12/19/2024 |
| K043396 | VIVOSONIC, INC. | INTEGRITY, MODEL V500 | 01/24/2005 |
| K080060 | VIVOSONIC, INC. | VIVOSONIC NEUROSCREEN | 04/04/2008 |
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