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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
Jul 3, 2001K011114ETYMOTIC RESEARCH ER-10D OAE PROBE
Etymotic Research
EWO
Jun 25, 2001K011181ICS MEDICAL CHARTR OAE WITH TYMP
Ics Medical Corp.
EWO
Mar 16, 2001K003913HINT AUDIOMETER, OR HINT
Maico-Diagnostics
EWO
Mar 12, 2001K010165ERO SCAN OAE TEST SYSTEM
Etymotic Research
EWO
Aug 25, 2000K002200CAPELLA
Madsen Electronics, Inc.
EWO
Jun 2, 2000K001058AUDIOSCREENER OAE + ABR
Kedly, Inc.
EWO
Feb 24, 2000K994033HORTMANN ECHOMASTER OAE ANALYZER
Hortmann AG
EWO
Feb 11, 2000K000184AUDIOSCREENER OAE
Kedly, Inc.
EWO
Mar 19, 1999K984547DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
Resound Corp.
EWO
Jan 29, 1999K983915AMPLAID A315 AND A319
Amplifon S.P.A.
EWO
Jan 28, 1999K983851CAPELLA COCHLEAR EMISSIONS ANALYZER
Madsen Electronics, Inc.
EWO
Jan 12, 1999K983712AMPLAID A311 SERIES
Amplifon S.P.A.
EWO
Dec 11, 1998K983352ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
Otodynamics, Ltd.
EWO
Dec 11, 1998K983351ILO292 DP ECHOPORT PLUS OAE SYSTEM
Otodynamics, Ltd.
EWO
Dec 11, 1998K983350ILO292 DP ECHOPORT PLUS OAE SYSTEM
Otodynamics, Ltd.
EWO
Nov 17, 1998K983048AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
American Electromedics Corp.
EWO
Nov 3, 1998K982878EARSCAN 3
Micro Audiometrics Corp.
EWO
Oct 28, 1998K982723MAICO MA42
Bernafon-Maico, Inc.
EWO
Oct 21, 1998K982642ECHO-SCREEN
Fischer-Zoth Audiologic Systems, Inc.
EWO
Oct 21, 1998K982566AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
Bar - Advanced Control Systems , Ltd., IL
EWO
Oct 9, 1998K982441CCA-220
Benson Medical Instruments Co.
EWO
Aug 7, 1998K982249INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
Idem (Int'L Dist. of Electronics For Medicine)
EWO
Jul 24, 1998K981511OTO WIZZARD
Medrx, Inc.
EWO
Jun 15, 1998K981439CCA-200
Benson Medical Instruments Co.
EWO
May 20, 1998K981460CUB DIS II DPOAE MEASUREMENT SYSTEM
Mimosa Acoustics, Inc.
EWO
May 11, 1998K981327INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
Idem (Int'L Dist. of Electronics For Medicine)
EWO
Apr 22, 1998K981142MAICO MA53
Bernafon-Maico, Inc.
EWO
Apr 7, 1998K980505HORTMANN AMDIS-OAE OAE ANALYZER
Hortmann AG
EWO
Mar 23, 1998K980533ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
Etymotic Research
EWO
Mar 10, 1998K973377SIBELMED AC50D
Trutone
EWO
Feb 10, 1998K974237GSI 70 AUDIOPATH SCREENER
Grason-Stadler, Inc.
EWO
Jan 22, 1998K974076SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
Bio-Logic Systems Corp.
EWO
Nov 25, 1997K973320ARTICULATE FITTING SYSTEM
Decibel Instruments, Inc.
EWO
Oct 31, 1997K972862AMPLAID 171S
Amplifon S.P.A.
EWO
Sep 8, 1997K972221K 15 AUDIOMETER
American Electromedics Corp.
EWO
Aug 5, 1997K971747AMPLAID 460
Amplifon S.P.A.
EWO
Jun 6, 1997K971080MAICO MA52
Bernafon-Maico, Inc.
EWO
May 13, 1997K964132MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
Bio-Logic Systems Corp.
EWO
Mar 18, 1997K970279RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
American Electromedics Corp.
EWO
Mar 17, 1997K970555IL0292 DP ECHOPORT
Smith
EWO
Feb 3, 1997K964426SMARTOAE
Intelligent Hearing Systems
EWO
Jan 10, 1997K964340PORTAREM-3000, PFS-6000
Starkey Laboratories, Inc.
EWO
Jan 10, 1997K962995ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
Otodynamics, Ltd., GB
EWO
Oct 8, 1996K963681CCA-100 (MODIFIED)
Benson Medical Instruments Co.
EWO
Sep 5, 1996K962275MAICO MA25 SERIES II WITH SPEECH
Bernafon-Maico, Inc.
EWO
Aug 21, 1996K962012ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
Ethical Hearing Instruments
EWO
May 29, 1996K961447SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
Bio-Logic Systems Corp.
EWO
Dec 21, 1995K953814OTOSCAPE
Soundscape Technologies, Inc., CA
EWO
Oct 27, 1995K953884PROPHET
Qualitone
EWO
Oct 27, 1995K953684GSI 61 CLINICAL AUDIOMETER
Grason-Stadler, Inc.
EWO

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