ETY · Class II · 21 CFR 874.1090

FDA Product Code ETY: Tester, Auditory Impedance

Leading manufacturers include American Electromedics Corp., Maico Hearing Instruments, Inc. and Madsen Electronics (Canada) , Ltd..

70
Total
70
Cleared
93d
Avg days
1980
Since

FDA 510(k) Cleared Tester, Auditory Impedance Devices (Product Code ETY)

70 devices
1–24 of 70
Cleared Mar 06, 2019
Hearing Healthcare Pro
K183201
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 107d
Cleared Aug 02, 2017
Hearing Healthcare Pro
K171038
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 118d
Cleared Nov 16, 2016
touchTymp
K162210
Maico Diagnostics GmbH
Ear, Nose, Throat · 103d
Cleared Sep 01, 2016
Madsen Zodiac
K161707
Gn Otometrics
Ear, Nose, Throat · 72d
Cleared Jul 15, 2015
AT235
K151616
Interacoustics A/S
Ear, Nose, Throat · 30d
Cleared Jun 25, 2015
GSI TympStar Pro Middle Ear Analyzer
K151509
Diagnostic Group, Dba Grason-Stadler
Ear, Nose, Throat · 21d
Cleared Jan 24, 2014
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
K133013
Inventis S.R.L.
Ear, Nose, Throat · 121d
Cleared Nov 29, 2012
TITAN
K121847
Interacoustics A/S
Ear, Nose, Throat · 157d
Cleared Apr 09, 2009
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
K083861
Interacoustics AS
Ear, Nose, Throat · 106d
Cleared Jul 16, 2008
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
K081841
Amplivox, Ltd.
Ear, Nose, Throat · 16d
Cleared Mar 02, 2007
EARCHECK ACOUSTIC REFLECTOMETER
K070312
Innovia Medical, LLC
Ear, Nose, Throat · 29d
Cleared Apr 12, 2000
GSI 2000 MIDDLE EAR ANALYZER
K000097
Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Mar 14, 2000
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
K994254
International Distributors of Electronics For Medi
Ear, Nose, Throat · 88d
Cleared Dec 28, 1999
PASCAL MEDICAL AB MENIETT 20
K991562
Pascal Medical AB
Ear, Nose, Throat · 238d
Cleared Sep 20, 1999
AMPLAID A724 AND A728
K992370
Amplifon S.P.A.
Ear, Nose, Throat · 67d
Cleared May 17, 1999
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
K990585
Idem (Int'L Dist. of Electronics For Medicine)
Ear, Nose, Throat · 83d
Cleared May 17, 1999
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
K990652
Idem (Int'L Dist. of Electronics For Medicine)
Ear, Nose, Throat · 77d
Cleared Jan 25, 1999
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
K983832
Idem (Int'L Dist. of Electronics For Medicine)
Ear, Nose, Throat · 87d
Cleared Nov 18, 1998
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
K983049
American Electromedics Corp.
Ear, Nose, Throat · 78d
Cleared Nov 18, 1998
AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
K983051
American Electromedics Corp.
Ear, Nose, Throat · 78d
Cleared Nov 17, 1998
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
K983046
American Electromedics Corp.
Ear, Nose, Throat · 77d
Cleared Feb 10, 1998
AMPLAID AM50
K974235
Amplifon S.P.A.
Ear, Nose, Throat · 90d
Cleared Aug 18, 1997
EARCHECK
K971859
Mdi Instruments, Inc.
Ear, Nose, Throat · 90d
Cleared May 28, 1997
EARCHECK PRO
K970685
Mdi Instruments, Inc.
Ear, Nose, Throat · 93d

About Product Code ETY - Regulatory Context