FDA 510(k) Applications for Medical Device Product Code "EWO"
(Audiometer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K103298 | ACOUSTICON GMBH | ACAM 5 AUDIOMETER SYSTEM | 04/08/2011 |
| K983048 | AMERICAN ELECTROMEDICS CORP. | AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | 11/17/1998 |
| K972221 | AMERICAN ELECTROMEDICS CORP. | K 15 AUDIOMETER | 09/08/1997 |
| K970279 | AMERICAN ELECTROMEDICS CORP. | RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) | 03/18/1997 |
| K972862 | AMPLIFON S.P.A. | AMPLAID 171S | 10/31/1997 |
| K971747 | AMPLIFON S.P.A. | AMPLAID 460 | 08/05/1997 |
| K983712 | AMPLIFON S.P.A. | AMPLAID A311 SERIES | 01/12/1999 |
| K983915 | AMPLIFON S.P.A. | AMPLAID A315 AND A319 | 01/29/1999 |
| K092089 | AUDIGENCE, INC. | CLARUJUST | 03/10/2010 |
| K982566 | BAR - ADVANCED CONTROL SYSTEMS LTD. | AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) | 10/21/1998 |
| K963681 | BENSON MEDICAL INSTRUMENTS CO. | CCA-100 (MODIFIED) | 10/08/1996 |
| K981439 | BENSON MEDICAL INSTRUMENTS CO. | CCA-200 | 06/15/1998 |
| K982441 | BENSON MEDICAL INSTRUMENTS CO. | CCA-220 | 10/09/1998 |
| K962275 | BERNAFON-MAICO, INC. | MAICO MA25 SERIES II WITH SPEECH | 09/05/1996 |
| K982723 | BERNAFON-MAICO, INC. | MAICO MA42 | 10/28/1998 |
| K971080 | BERNAFON-MAICO, INC. | MAICO MA52 | 06/06/1997 |
| K981142 | BERNAFON-MAICO, INC. | MAICO MA53 | 04/22/1998 |
| K122496 | BIO-LOGIC SYSTEMS CORP. | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | 11/01/2012 |
| K021801 | BIO-LOGIC SYSTEMS CORP. | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS | 06/27/2002 |
| K031352 | BIO-LOGIC SYSTEMS CORP. | BIO-LOGIC INSERT EARPHONES | 07/16/2003 |
| K061744 | BIO-LOGIC SYSTEMS CORP. | COCHLEA-SCAN / COCHLEA-SCAN PLUS | 09/15/2006 |
| K964132 | BIO-LOGIC SYSTEMS CORP. | MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT | 05/13/1997 |
| K961447 | BIO-LOGIC SYSTEMS CORP. | SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT | 05/29/1996 |
| K121512 | BIO-LOGIC SYSTEMS CORP. | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | 07/26/2012 |
| K974076 | BIO-LOGIC SYSTEMS CORP. | SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE | 01/22/1998 |
| K973320 | DECIBEL INSTRUMENTS, INC. | ARTICULATE FITTING SYSTEM | 11/25/1997 |
| K092244 | DIAGNOSTIC GROUP LLC | MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS | 03/01/2010 |
| K112992 | EARLOGIC CORPORATION | EARLOGIC OAE TESTER | 04/20/2012 |
| K092111 | ENTOMED AB | ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 | 10/02/2009 |
| K962012 | ETHICAL HEARING INSTRUMENTS | ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER | 08/21/1996 |
| K010165 | ETYMOTIC RESEARCH | ERO SCAN OAE TEST SYSTEM | 03/12/2001 |
| K980533 | ETYMOTIC RESEARCH | ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) | 03/23/1998 |
| K011114 | ETYMOTIC RESEARCH | ETYMOTIC RESEARCH ER-10D OAE PROBE | 07/03/2001 |
| K070880 | ETYMOTIC RESEARCH, INC. | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | 06/07/2007 |
| K112733 | ETYMOTIC RESEARCH, INC. | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | 12/16/2011 |
| K150491 | ETYMOTIC RESEARCH, INC. | ER36 Series OAE Test System | 03/26/2015 |
| K024205 | EVEREST BIOMEDICAL INSTRUMENTS CO. | AUDIOSCREENER OAE+ABR | 03/07/2003 |
| K982642 | FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. | ECHO-SCREEN | 10/21/1998 |
| K081234 | GN OTOMETRICS | GN OTOMETRICS INSERT EARPHONES | 07/14/2008 |
| K180287 | Grason-Stadler Inc. | GSI Corti | 05/11/2018 |
| K172403 | Grason-Stadler Inc. | GSI Novus | 10/20/2017 |
| K974237 | GRASON-STADLER, INC. | GSI 70 AUDIOPATH SCREENER | 02/10/1998 |
| K980505 | HORTMANN AG | HORTMANN AMDIS-OAE OAE ANALYZER | 04/07/1998 |
| K994033 | HORTMANN AG | HORTMANN ECHOMASTER OAE ANALYZER | 02/24/2000 |
| K031986 | ICS MEDICAL | ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS | 07/24/2003 |
| K011181 | ICS MEDICAL CORP. | ICS MEDICAL CHARTR OAE WITH TYMP | 06/25/2001 |
| K981327 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) | INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER | 05/11/1998 |
| K982249 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) | INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER | 08/07/1998 |
| K151025 | IHEAR MEDICAL, INC. | iHearTest | 12/29/2015 |
| K964426 | INTELLIGENT HEARING SYSTEMS | SMARTOAE | 02/03/1997 |
| K023859 | INTELLIGENT HEARING SYSTEMS | SMARTTROAE | 01/08/2003 |
| K191372 | Interacoustics A/S | Lyra | 07/15/2019 |
| K060883 | INTERACOUSTICS A/S | PILOT TEST OR DETECTIVE AUDIOMETERS | 06/23/2006 |
| K173567 | Interacoustics A/S | Sera | 02/14/2018 |
| K130795 | INTERACOUSTICS A/S | TITAN | 06/20/2013 |
| K060539 | INTERACOUSTICS A/S, ASSENS | DPOAE20 , ECLIPSE | 05/30/2006 |
| K030016 | INTERACOUSTICS A/S, ASSENS | TEOAE25 | 03/28/2003 |
| K043219 | INTERACOUSTICS AS | AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS | 02/04/2005 |
| K052562 | INTERACOUSTICS AS | ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. | 12/23/2005 |
| K090406 | INTERACOUSTICS AS | EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE | 07/22/2009 |
| K000184 | KEDLY, INC. | AUDIOSCREENER OAE | 02/11/2000 |
| K001058 | KEDLY, INC. | AUDIOSCREENER OAE + ABR | 06/02/2000 |
| K002200 | MADSEN ELECTRONICS, INC. | CAPELLA | 08/25/2000 |
| K983851 | MADSEN ELECTRONICS, INC. | CAPELLA COCHLEAR EMISSIONS ANALYZER | 01/28/1999 |
| K063452 | MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC) | MA 55 MAESTRO | 03/29/2007 |
| K171506 | Maico Diagnostics GmbH | Easyscreen | 08/29/2017 |
| K003913 | MAICO-DIAGNOSTICS | HINT AUDIOMETER, OR HINT | 03/16/2001 |
| K060885 | MAICO-DIAGNOSTICS | MODEL MI 44 TYMPANOMETER | 06/05/2006 |
| K981511 | MEDRX, INC. | OTO WIZZARD | 07/24/1998 |
| K982878 | MICRO AUDIOMETRICS CORP. | EARSCAN 3 | 11/03/1998 |
| K981460 | MIMOSA ACOUSTICS, INC. | CUB DIS II DPOAE MEASUREMENT SYSTEM | 05/20/1998 |
| K053216 | MIMOSA ACOUSTICS, INC. | HEARID WIDEBAND MIDDLE EAR POWER ANALYZER | 02/10/2006 |
| K063338 | MIMOSA ACOUSTICS, INC. | HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER | 01/04/2007 |
| K123624 | MIMOSA ACOUSTICS, INC. | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | 03/28/2013 |
| K112247 | NATUS MEDICAL INCORPORATED | A BAER WITH ABAER I/O FUNCTION | 04/02/2012 |
| K111618 | NATUS MEDICAL INCORPORATED | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | 12/28/2011 |
| K011135 | NICOLET BIOMEDICAL | GSI AUDERA | 07/26/2001 |
| K983352 | OTODYNAMICS, LTD. | ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK | 12/11/1998 |
| K983350 | OTODYNAMICS, LTD. | ILO292 DP ECHOPORT PLUS OAE SYSTEM | 12/11/1998 |
| K983351 | OTODYNAMICS, LTD. | ILO292 DP ECHOPORT PLUS OAE SYSTEM | 12/11/1998 |
| K962995 | OTODYNAMICS, LTD. | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC | 01/10/1997 |
| K072033 | OTODYNAMICS, LTD. | OTODYNAMICS OTOPORT | 11/13/2007 |
| K143395 | OTODYNAMICS, LTD. | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit | 02/23/2015 |
| K133012 | PATH MEDICAL GMBH | SENTIERO | 06/09/2014 |
| K213345 | Path Medical GmbH | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | 06/22/2022 |
| K984547 | RESOUND CORP. | DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS | 03/19/1999 |
| K970555 | SMITH | IL0292 DP ECHOPORT | 03/17/1997 |
| K964340 | STARKEY LABORATORIES, INC. | PORTAREM-3000, PFS-6000 | 01/10/1997 |
| K141524 | TELEEMG, LLC USA | NEURO-AUDIO | 03/12/2015 |
| K973377 | TRUTONE | SIBELMED AC50D | 03/10/1998 |
| K070118 | TYMPANY, INC. | OTOGRAM, CA3350 | 03/07/2007 |
| K031713 | VIASYS HEALTHCARE, INC. | AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS | 08/12/2003 |
| K003364 | VIVOSONIC, INC. | VIVO 200 DPS VIVOSCAN | 07/18/2001 |
| K033108 | VIVOSONIC, INC. | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER | 10/27/2003 |
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