ETW · Class II · 21 CFR 874.3310

FDA Product Code ETW: Calibrator, Hearing Aid / Earphone And Analysis Systems

Leading manufacturers include Starkey Laboratories, Inc., Madsen Electronics (Canada) , Ltd. and Siemens Hearing Instruments, Inc..

46
Total
46
Cleared
76d
Avg days
1980
Since

FDA 510(k) Cleared Calibrator, Hearing Aid / Earphone And Analysis Systems Devices (Product Code ETW)

46 devices
1–24 of 46
Cleared Oct 23, 2012
AURICAL HIT
K122028
Gn Otometrics
Ear, Nose, Throat · 105d
Cleared Apr 19, 2012
PRIMUS HEARING INSTRUMENT TEST UNIT
K113831
Auditdata A/S
Ear, Nose, Throat · 114d
Cleared Apr 28, 2011
GN OTOMETRICS TYPE 1053 FREEFIT
K110286
Gn Otometrics A/S
Ear, Nose, Throat · 87d
Cleared Jun 05, 2007
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared Mar 18, 1998
FONIX FP35 HEARING AID ANALYZER
K980377
Frye Electronics, Inc.
Ear, Nose, Throat · 44d
Cleared Jun 06, 1997
GSI SA60 DPOAE SYSTEM
K970324
Grason-Stadler, Inc.
Ear, Nose, Throat · 130d
Cleared Mar 07, 1996
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
K960229
Resound Corp.
Ear, Nose, Throat · 50d
Cleared May 25, 1995
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
K952098
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Oct 21, 1994
DESKREM-1000
K943459
Starkey Laboratories, Inc.
Ear, Nose, Throat · 95d
Cleared Oct 21, 1994
PORTAREM 2000
K943460
Starkey Laboratories, Inc.
Ear, Nose, Throat · 95d
Cleared Feb 13, 1989
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
K884371
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 118d
Cleared Feb 13, 1989
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
K884372
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 118d
Cleared Apr 16, 1987
AUDIOMETER
K870337
Bio-Logic Systems Corp.
Ear, Nose, Throat · 78d
Cleared Mar 13, 1987
HEARING AID TEST SYSTEM MODEL HAT 1000
K870229
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 51d
Cleared Jul 18, 1986
PHONIC EAR, MODEL PE 1800
K862162
Phonic Ear, Inc.
Ear, Nose, Throat · 42d
Cleared Jun 09, 1986
PHONIC EAR
K861857
Phonic Ear, Inc.
Ear, Nose, Throat · 26d
Cleared Feb 20, 1986
INSERTION GAIN OPTIMIZER IGO-1000
K854535
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 16, 1986
HEARING AID ANALYSIS SYSTEM
K853271
Robert Bosch Corp.
Ear, Nose, Throat · 164d
Cleared Dec 03, 1984
STARKET MODEL HMS
K844275
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 03, 1982
STARKEY MODEL HAL-1
K821908
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d

About Product Code ETW - Regulatory Context