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 |
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 |
K043396 |
VIVOSONIC, INC. |
INTEGRITY, MODEL V500 |
01/24/2005 |
K080060 |
VIVOSONIC, INC. |
VIVOSONIC NEUROSCREEN |
04/04/2008 |