Panels › Ear, Nose, Throat › Product code ETW · Class 2
Calibrator, Hearing Aid / Earphone And Analysis Systems
Regulation 874.3310
0510(k)s in 12 months (46 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ETW
| Company | 510(k)s | Recalls |
|---|---|---|
| Frye Electronics, Inc. | 9 | 0 |
| Madsen Electronics (Canada) , Ltd. | 4 | 0 |
| Starkey Laboratories, Inc. | 4 | 0 |
| Rastronics USA, Inc. | 3 | 0 |
| Etymonic Design, Inc. | 2 | 0 |
| Gn Otometrics A/S | 2 | 0 |
| Phonic Ear, Inc. | 2 | 0 |
| Precision Acoustics Ind., Inc. | 2 | 0 |
| Siemens Hearing Instruments, Inc. | 2 | 0 |
| A/S Bruel & Kjaer | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2012 | K122028 | AURICAL HIT Gn Otometrics | ETW |
| Apr 19, 2012 | K113831 | PRIMUS HEARING INSTRUMENT TEST UNIT Auditdata A/S, DK | ETW |
| Apr 28, 2011 | K110286 | GN OTOMETRICS TYPE 1053 FREEFIT Gn Otometrics A/S | ETW |
| Dec 30, 2009 | K093006 | FONIX ,MODEL 8000 Frye Electronics, Inc. | ETW |
| Jun 5, 2007 | K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) Siemens Hearing Instruments, Inc. | ETW |
| May 3, 2006 | K061104 | SPEECHLINK 100 TYPE 1053 Gn Otometrics A/S, DK | ETW |
| Apr 29, 2005 | K050496 | REM440 Interacoustics A/S, Assens | ETW |
| Sep 3, 2004 | K041853 | OTOGRAM Tympany, Inc. | ETW |
| Aug 27, 2002 | K022510 | FONIX, MODEL 7000 Frye Electronics, Inc. | ETW |
| Sep 21, 2001 | K012306 | AUDIOSCAN VERIFIT, MODEL VF-1 Etymonic Design, Inc., CA | ETW |
| Mar 18, 1998 | K980377 | FONIX FP35 HEARING AID ANALYZER Frye Electronics, Inc. | ETW |
| Jun 6, 1997 | K970324 | GSI SA60 DPOAE SYSTEM Grason-Stadler, Inc. | ETW |
| Mar 7, 1996 | K960229 | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM Resound Corp. | ETW |
| May 25, 1995 | K952098 | SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE Siemens Hearing Instruments, Inc. | ETW |
| Oct 21, 1994 | K943460 | PORTAREM 2000 Starkey Laboratories, Inc. | ETW |
| Oct 21, 1994 | K943459 | DESKREM-1000 Starkey Laboratories, Inc. | ETW |
| Sep 23, 1994 | K943607 | INTERACOUSTICS HEARING AID ANALYZER MS 40 Precision Acoustics Ind., Inc. | ETW |
| May 23, 1994 | K941848 | INTERACOUSTICS. HEARING AID ANALYZER Precision Acoustics Ind., Inc. | ETW |
| Jan 21, 1994 | K934342 | GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM Glaser Instruments AG, CH | ETW |
| Jan 14, 1994 | K935400 | FONIX 3500 HEARING AID ANALYZER Frye Electronics, Inc. | ETW |
| Oct 5, 1990 | K902244 | RASTRONICS CCI 8 Rastronics USA, Inc. | ETW |
| Sep 12, 1990 | K902252 | RASTRONICS CCI 10/3 HEARING AID ANALYSIS Rastronics USA, Inc. | ETW |
| Aug 9, 1990 | K896996 | CAS (COMPUTERIZED ANALYZER SYSTEM) Gn Danavox, Inc. | ETW |
| Feb 8, 1990 | K896477 | NICOLET REAL EAR ANALYZER Nicolet Instrument Corp. | ETW |
| Jan 22, 1990 | K895383 | TYPE FP40 DIGITAL HEARING AID ANALYZER Frye Electronics, Inc. | ETW |
| Jan 16, 1990 | K896301 | MODEL 340 PROBE MIC SYSTEM Virtual Corp. | ETW |
| Feb 13, 1989 | K884372 | MADSEN IGO1500 INSERTION GAIN OPTIMIZER Madsen Electronics (Canada) , Ltd., CA | ETW |
| Feb 13, 1989 | K884371 | MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM Madsen Electronics (Canada) , Ltd., CA | ETW |
| Feb 13, 1989 | K884046 | AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 Etymonic Design, Inc., CA | ETW |
| Sep 16, 1987 | K872633 | MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM Hearing Health Care Program | ETW |
| Jul 10, 1987 | K872242 | TYPE 6400 REAL EAR HEARING AID ANALYZER Frye Electronics, Inc. | ETW |
| Apr 16, 1987 | K870337 | AUDIOMETER Bio-Logic Systems Corp. | ETW |
| Mar 13, 1987 | K870229 | HEARING AID TEST SYSTEM MODEL HAT 1000 Madsen Electronics (Canada) , Ltd., CA | ETW |
| Aug 15, 1986 | K862026 | HA-2000 REAL EAR SPECTROSCOPE And/Or Corp. | ETW |
| Jul 18, 1986 | K862162 | PHONIC EAR, MODEL PE 1800 Phonic Ear, Inc. | ETW |
| Jul 16, 1986 | K862086 | IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 A/S Bruel & Kjaer, DK | ETW |
| Jun 9, 1986 | K861857 | PHONIC EAR Phonic Ear, Inc. | ETW |
| May 30, 1986 | K861571 | TYPE 6500 HEARING AID ANALYZER Frye Electronics, Inc. | ETW |
| Apr 23, 1986 | K861113 | ER-7C CLINICAL PROBE MICROPHONE Etymotic Research | ETW |
| Feb 20, 1986 | K854535 | INSERTION GAIN OPTIMIZER IGO-1000 Madsen Electronics (Canada) , Ltd., CA | ETW |
| Jan 16, 1986 | K853271 | HEARING AID ANALYSIS SYSTEM Robert Bosch Corp. | ETW |
| Sep 27, 1985 | K853320 | FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 Rastronics USA, Inc. | ETW |
| May 29, 1985 | K850918 | TYPE FP30 DIGITAL HEARING AID ANALYZER Frye Electronics, Inc. | ETW |
| Dec 3, 1984 | K844275 | STARKET MODEL HMS Starkey Laboratories, Inc. | ETW |
| Aug 3, 1982 | K821908 | STARKEY MODEL HAL-1 Starkey Laboratories, Inc. | ETW |
| Aug 27, 1980 | K801905 | FONIX TYPE 5100 HEARING AID ANALYZER Frye Electronics, Inc. | ETW |
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