Calibrator, Hearing Aid / Earphone And Analysis Systems
FDA product code ETW · Class II (moderate risk) · 21 CFR 874.3310 · Ear, Nose, Throat
46510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Frye Electronics, Inc. 9
- Starkey Laboratories, Inc. 4
- Madsen Electronics (Canada) , Ltd. 4
- Rastronics USA, Inc. 3
- Gn Otometrics A/S 2
- Siemens Hearing Instruments, Inc. 2
- Precision Acoustics Ind., Inc. 2
- Etymonic Design, Inc. 2
- Phonic Ear, Inc. 2
- And/Or Corp. 1
- Bio-Logic Systems Corp. 1
- Hearing Health Care Program 1
- A/S Bruel & Kjaer 1
- Virtual Corp. 1
- Nicolet Instrument Corp. 1
- Gn Danavox, Inc. 1
- Glaser Instruments AG 1
- Etymotic Research 1
- Resound Corp. 1
- Gn Otometrics 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122028 | Aurical HitETW · Traditional | Gn Otometrics | 10/23/2012SE |
| K113831 | Primus Hearing Instrument Test UnitETW · Traditional | Auditdata A/S | 04/19/2012SE |
| K110286 | GN Otometrics Type 1053 FreefitETW · Traditional | Gn Otometrics A/S | 04/28/2011SE |
| K093006 | Fonix ,Model 8000ETW · Abbreviated | Frye Electronics, Inc. | 12/30/2009SE |
| K071462 | Unity 2 Hia & Probe ( for Use with Unity 2)ETW · Traditional | Siemens Hearing Instruments, Inc. | 06/05/2007SE |
| K061104 | Speechlink 100 Type 1053ETW · Traditional | Gn Otometrics A/S | 05/03/2006SE |
| K050496 | REM440ETW · Traditional | Interacoustics A/S, Assens | 04/29/2005SE |
| K041853 | OtogramETW · Traditional | Tympany, Inc. | 09/03/2004SE |
| K022510 | Fonix, Model 7000ETW · Abbreviated | Frye Electronics, Inc. | 08/27/2002SE |
| K012306 | Audioscan Verifit, Model VF-1ETW · Traditional | Etymonic Design, Inc. | 09/21/2001SE |
| K980377 | Fonix FP35 Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 03/18/1998SE |
| K970324 | Gsi SA60 Dpoae SystemETW · Traditional | Grason-Stadler, Inc. | 06/06/1997SE |
| K960229 | Resound Real Ear Loudness Mapping (Relm) SystemETW · Traditional | Resound Corp. | 03/07/1996SE |
| K952098 | Siemens PC Auidiometer Model SD 100 & PC Probe Mic System Model SD 110/SD with Unity…ETW · Traditional | Siemens Hearing Instruments, Inc. | 05/25/1995SE |
| K943460 | Portarem 2000ETW · Traditional | Starkey Laboratories, Inc. | 10/21/1994SE |
| K943459 | DESKREM-1000ETW · Traditional | Starkey Laboratories, Inc. | 10/21/1994SE |
| K943607 | Interacoustics Hearing Aid Analyzer MS 40ETW · Traditional | Precision Acoustics Ind., Inc. | 09/23/1994SE |
| K941848 | Interacoustics. Hearing Aid AnalyzerETW · Traditional | Precision Acoustics Ind., Inc. | 05/23/1994SE |
| K934342 | Glaser RT450 Hearing Aid Test and Analysis SystemETW · Traditional | Glaser Instruments AG | 01/21/1994SE |
| K935400 | Fonix 3500 Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 01/14/1994SE |
| K902244 | Rastronics Cci 8ETW · Traditional | Rastronics USA, Inc. | 10/05/1990SE |
| K902252 | Rastronics Cci 10/3 Hearing Aid AnalysisETW · Traditional | Rastronics USA, Inc. | 09/12/1990SE |
| K896996 | Cas (Computerized Analyzer System)ETW · Traditional | Gn Danavox, Inc. | 08/09/1990SE |
| K896477 | Nicolet Real Ear AnalyzerETW · Traditional | Nicolet Instrument Corp. | 02/08/1990SE |
| K895383 | Type FP40 Digital Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 01/22/1990SE |
| K896301 | Model 340 Probe Mic SystemETW · Traditional | Virtual Corp. | 01/16/1990SE |
| K884372 | Madsen IGO1500 Insertion Gain OptimizerETW · Traditional | Madsen Electronics (Canada) , Ltd. | 02/13/1989SE |
| K884371 | Madsen IGO-HAT1500 Hearing Aid Dispenser SystemETW · Traditional | Madsen Electronics (Canada) , Ltd. | 02/13/1989SE |
| K884046 | Audioscan(Tm) Real Ear Measurement System RM500ETW · Traditional | Etymonic Design, Inc. | 02/13/1989SE |
| K872633 | Master-Fit Hearing Evalua. & Recom. (Hear) SystemETW · Traditional | Hearing Health Care Program | 09/16/1987SE |
| K872242 | Type 6400 Real Ear Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 07/10/1987SE |
| K870337 | AudiometerETW · Traditional | Bio-Logic Systems Corp. | 04/16/1987SE |
| K870229 | Hearing Aid Test System Model Hat 1000ETW · Traditional | Madsen Electronics (Canada) , Ltd. | 03/13/1987SE |
| K862026 | HA-2000 Real Ear SpectroscopeETW · Traditional | And/Or Corp. | 08/15/1986SE |
| K862162 | Phonic Ear, Model Pe 1800ETW · Traditional | Phonic Ear, Inc. | 07/18/1986SE |
| K862086 | In Situ Ear Gain Audio Test Stat Type 2118/WH 1823ETW · Traditional | A/S Bruel & Kjaer | 07/16/1986SE |
| K861857 | Phonic EarETW · Traditional | Phonic Ear, Inc. | 06/09/1986SE |
| K861571 | Type 6500 Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 05/30/1986SE |
| K861113 | ER-7C Clinical Probe MicrophoneETW · Traditional | Etymotic Research | 04/23/1986SE |
| K854535 | Insertion Gain Optimizer IGO-1000ETW · Traditional | Madsen Electronics (Canada) , Ltd. | 02/20/1986SE |
| K853271 | Hearing Aid Analysis SystemETW · Traditional | Robert Bosch Corp. | 01/16/1986SE |
| K853320 | Frequency Response Analyzer Computer Sys CCI-10ETW · Traditional | Rastronics USA, Inc. | 09/27/1985SE |
| K850918 | Type FP30 Digital Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 05/29/1985SE |
| K844275 | Starket Model HMSETW · Traditional | Starkey Laboratories, Inc. | 12/03/1984SE |
| K821908 | Starkey Model HAL-1ETW · Traditional | Starkey Laboratories, Inc. | 08/03/1982SE |
| K801905 | Fonix Type 5100 Hearing Aid AnalyzerETW · Traditional | Frye Electronics, Inc. | 08/27/1980SE |