ETW · Class II · 21 CFR 874.3310

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

Leading manufacturers include Frye Electronics, Inc., Starkey Laboratories, Inc. and Madsen Electronics (Canada) , Ltd..

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 Dec 30, 2009
FONIX ,MODEL 8000
K093006
Frye Electronics, Inc.
Ear, Nose, Throat · 93d
Cleared Jun 05, 2007
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared May 03, 2006
SPEECHLINK 100 TYPE 1053
K061104
Gn Otometrics A/S
Ear, Nose, Throat · 13d
Cleared Apr 29, 2005
REM440
K050496
Interacoustics A/S, Assens
Ear, Nose, Throat · 60d
Cleared Sep 03, 2004
OTOGRAM
K041853
Tympany, Inc.
Ear, Nose, Throat · 57d
Cleared Aug 27, 2002
FONIX, MODEL 7000
K022510
Frye Electronics, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 21, 2001
AUDIOSCAN VERIFIT, MODEL VF-1
K012306
Etymonic Design, Inc.
Ear, Nose, Throat · 60d
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 Sep 23, 1994
INTERACOUSTICS HEARING AID ANALYZER MS 40
K943607
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 60d
Cleared May 23, 1994
INTERACOUSTICS. HEARING AID ANALYZER
K941848
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 39d
Cleared Jan 21, 1994
GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
K934342
Glaser Instruments AG
Ear, Nose, Throat · 136d
Cleared Jan 14, 1994
FONIX 3500 HEARING AID ANALYZER
K935400
Frye Electronics, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 05, 1990
RASTRONICS CCI 8
K902244
Rastronics USA, Inc.
Ear, Nose, Throat · 140d
Cleared Sep 12, 1990
RASTRONICS CCI 10/3 HEARING AID ANALYSIS
K902252
Rastronics USA, Inc.
Ear, Nose, Throat · 114d
Cleared Aug 09, 1990
CAS (COMPUTERIZED ANALYZER SYSTEM)
K896996
Gn Danavox, Inc.
Ear, Nose, Throat · 241d
Cleared Feb 08, 1990
NICOLET REAL EAR ANALYZER
K896477
Nicolet Instrument Corp.
Ear, Nose, Throat · 87d

About Product Code ETW - Regulatory Context