EWO · Class II · 21 CFR 874.1050

FDA Product Code EWO: Audiometer

Leading manufacturers include Maico Hearing Instruments, Inc., Bio-Logic Systems Corp. and Otodynamics, Ltd..

235
Total
235
Cleared
103d
Avg days
1976
Since
235 devices
49–72 of 235
Cleared Oct 28, 1998
MAICO MA42
K982723
Bernafon-Maico, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 21, 1998
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
K982566
Bar - Advanced Control Systems , Ltd.
Ear, Nose, Throat · 90d
Cleared Oct 21, 1998
ECHO-SCREEN
K982642
Fischer-Zoth Audiologic Systems, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 09, 1998
CCA-220
K982441
Benson Medical Instruments Co.
Ear, Nose, Throat · 87d
Cleared Aug 07, 1998
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
K982249
Idem (Int'L Dist. of Electronics For Medicine)
Ear, Nose, Throat · 42d
Cleared Jul 24, 1998
OTO WIZZARD
K981511
Medrx, Inc.
Ear, Nose, Throat · 87d
Cleared Jun 15, 1998
CCA-200
K981439
Benson Medical Instruments Co.
Ear, Nose, Throat · 55d
Cleared May 20, 1998
CUB DIS II DPOAE MEASUREMENT SYSTEM
K981460
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 27d
Cleared May 11, 1998
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
K981327
Idem (Int'L Dist. of Electronics For Medicine)
Ear, Nose, Throat · 28d
Cleared Apr 22, 1998
MAICO MA53
K981142
Bernafon-Maico, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 07, 1998
HORTMANN AMDIS-OAE OAE ANALYZER
K980505
Hortmann AG
Ear, Nose, Throat · 57d
Cleared Mar 23, 1998
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
K980533
Etymotic Research
Ear, Nose, Throat · 40d
Cleared Mar 10, 1998
SIBELMED AC50D
K973377
Trutone
Ear, Nose, Throat · 183d
Cleared Feb 10, 1998
GSI 70 AUDIOPATH SCREENER
K974237
Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1998
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K974076
Bio-Logic Systems Corp.
Ear, Nose, Throat · 85d
Cleared Nov 25, 1997
ARTICULATE FITTING SYSTEM
K973320
Decibel Instruments, Inc.
Ear, Nose, Throat · 83d
Cleared Oct 31, 1997
AMPLAID 171S
K972862
Amplifon S.P.A.
Ear, Nose, Throat · 88d
Cleared Sep 08, 1997
K 15 AUDIOMETER
K972221
American Electromedics Corp.
Ear, Nose, Throat · 87d
Cleared Aug 05, 1997
AMPLAID 460
K971747
Amplifon S.P.A.
Ear, Nose, Throat · 85d
Cleared Jun 06, 1997
MAICO MA52
K971080
Bernafon-Maico, Inc.
Ear, Nose, Throat · 73d
Cleared May 13, 1997
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
K964132
Bio-Logic Systems Corp.
Ear, Nose, Throat · 210d
Cleared Mar 18, 1997
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
K970279
American Electromedics Corp.
Ear, Nose, Throat · 54d
Cleared Mar 17, 1997
IL0292 DP ECHOPORT
K970555
Smith
Ear, Nose, Throat · 32d
Cleared Feb 03, 1997
SMARTOAE
K964426
Intelligent Hearing Systems
Ear, Nose, Throat · 90d