ETY · Class II · 21 CFR 874.1090

FDA Product Code ETY: Tester, Auditory Impedance

Leading manufacturers include Maico Hearing Instruments, Inc., Life-Tech Intl., Inc. and Db Diagnostic Systems, Inc..

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 Jul 24, 1995
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
K953161
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 17d
Cleared Mar 18, 1993
HANDTYMP
K923072
Life-Tech Intl., Inc.
Ear, Nose, Throat · 266d
Cleared Feb 19, 1993
AUTOMATIC TYMPANOMETER
K923073
Life-Tech Intl., Inc.
Ear, Nose, Throat · 239d
Cleared Apr 30, 1991
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 130d
Cleared Jun 09, 1989
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293
Storz Instrument Co.
Ear, Nose, Throat · 309d
Cleared Jun 10, 1986
WELCH ALLYN TYMPANOMETER
K861516
Welch Allyn, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 18, 1984
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 07, 1983
MA 610-IMPEDANCE AUDIOMETER
K831754
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared Jul 06, 1983
MA600-IMPEDANCE AUDIOMETER
K831755
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 14, 1982
AURAL REFLEX INDICATOR
K822566
Kelleher Corp.
Ear, Nose, Throat · 21d

About Product Code ETY - Regulatory Context