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Panels › Ear, Nose, Throat › Product code EWO · Class 2

Audiometer

Regulation 874.1050

0510(k)s in 12 months (235 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in EWO

Company510(k)sRecalls
Maico Hearing Instruments, Inc.200
Grason-Stadler, Inc.120
Bio-Logic Systems Corp.90
Etymotic Research80
Otodynamics80
Tracor Instruments, Inc.70
American Electromedics Corp.60
Micro Audiometrics Corp.60
Beltone Electronics Corp.50
Madsen Electronics (Canada) , Ltd.50
Decided510(k)Device and applicantCode
Jun 21, 2024K234095OtoNova/OtoNova Pro
Otodynamics, GB
EWO
Mar 15, 2024K240430Otoport Pro
Otodynamics, Ltd., GB
EWO
Oct 27, 2023K231545hearOAE
Hearx SA (Pty) , Ltd., ZA
EWO
Jun 22, 2022K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
Path Medical GmbH, DE
EWO
Jul 15, 2019K191372Lyra
Interacoustics A/S, DK
EWO
May 11, 2018K180287GSI Corti
Grason-Stadler, Inc.
EWO
Feb 14, 2018K173567Sera
Interacoustics A/S, DK
EWO
Oct 20, 2017K172403GSI Novus
Grason-Stadler, Inc.
EWO
Aug 29, 2017K171506Easyscreen
Maico Diagnostics GmbH, DE
EWO
Dec 29, 2015K151025iHearTest
Ihear Medical, Inc.
EWO
Mar 26, 2015K150491ER36 Series OAE Test System
Etymotic Research, Inc.
EWO
Mar 12, 2015K141524NEURO-AUDIO
Teleemg, LLC USA
EWO
Feb 23, 2015K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otochec
Otodynamics, Ltd., GB
EWO
Jun 9, 2014K133012SENTIERO
Path Medical GmbH, DE
EWO
Jun 20, 2013K130795TITAN
Interacoustics A/S, DK
EWO
Mar 28, 2013K123624OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
Mimosa Acoustics, Inc.
EWO
Nov 1, 2012K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
Bio-Logic Systems Corp.
EWO
Jul 26, 2012K121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
Bio-Logic Systems Corp.
EWO
Apr 20, 2012K112992EARLOGIC OAE TESTER
Earlogic Corporation
EWO
Apr 2, 2012K112247A BAER WITH ABAER I/O FUNCTION
Natus Medical Incorporated
EWO
Dec 28, 2011K111618AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
Natus Medical Incorporated
EWO
Dec 16, 2011K112733ER35 ERO-SCAN PRO HEARING TEST SYSTEM
Etymotic Research, Inc.
EWO
Apr 8, 2011K103298ACAM 5 AUDIOMETER SYSTEM
Acousticon GmbH
EWO
Mar 10, 2010K092089CLARUJUST
Audigence, Inc.
EWO
Mar 1, 2010K092244MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
Diagnostic Group, LLC
EWO
Oct 2, 2009K092111ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
Entomed AB, SE
EWO
Jul 22, 2009K090406EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
Interacoustics AS, DK
EWO
Jul 14, 2008K081234GN OTOMETRICS INSERT EARPHONES
Gn Otometrics
EWO
Nov 13, 2007K072033OTODYNAMICS OTOPORT
Otodynamics, Ltd.
EWO
Jun 7, 2007K070880ER35 ERO-SCAN PRO HEARING TEST SYSTEM
Etymotic Research, Inc.
EWO
Mar 29, 2007K063452MA 55 MAESTRO
Maico Diagnostics (Diagnostic Group, LLC)
EWO
Mar 7, 2007K070118OTOGRAM, CA3350
Tympany, Inc.
EWO
Jan 4, 2007K063338HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
Mimosa Acoustics, Inc.
EWO
Sep 15, 2006K061744COCHLEA-SCAN / COCHLEA-SCAN PLUS
Bio-Logic Systems Corp.
EWO
Jun 23, 2006K060883PILOT TEST OR DETECTIVE AUDIOMETERS
Interacoustics A/S
EWO
Jun 5, 2006K060885MODEL MI 44 TYMPANOMETER
Maico-Diagnostics
EWO
May 30, 2006K060539DPOAE20 , ECLIPSE
Interacoustics A/S, Assens
EWO
Feb 10, 2006K053216HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
Mimosa Acoustics, Inc.
EWO
Dec 23, 2005K052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
Interacoustics AS
EWO
Feb 4, 2005K043219AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
Interacoustics AS
EWO
Oct 27, 2003K033108VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
Vivosonic, Inc., CA
EWO
Aug 12, 2003K031713AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
Viasys Healthcare, Inc.
EWO
Jul 24, 2003K031986ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
Ics Medical
EWO
Jul 16, 2003K031352BIO-LOGIC INSERT EARPHONES
Bio-Logic Systems Corp.
EWO
Mar 28, 2003K030016TEOAE25
Interacoustics A/S, Assens
EWO
Mar 7, 2003K024205AUDIOSCREENER OAE+ABR
Everest Biomedical Instruments Co.
EWO
Jan 8, 2003K023859SMARTTROAE
Intelligent Hearing Systems
EWO
Jun 27, 2002K021801BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
Bio-Logic Systems Corp.
EWO
Jul 26, 2001K011135GSI AUDERA
Nicolet Biomedical
EWO
Jul 18, 2001K003364VIVO 200 DPS VIVOSCAN
Vivosonic, Inc.
EWO

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