FDA Product Code
FDA Product Code ETW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3310
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122028 | AURICAL HIT | Gn Otometrics | 2012-10-23 | Traditional | PDF ↗ |
| K113831 | PRIMUS HEARING INSTRUMENT TEST UNIT | Auditdata A/S | 2012-04-19 | Traditional | PDF ↗ |
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | Gn Otometrics A/S | 2011-04-28 | Traditional | PDF ↗ |
| K093006 | FONIX ,MODEL 8000 | Frye Electronics, Inc. | 2009-12-30 | Abbreviated | PDF ↗ |
| K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | Siemens Hearing Instruments, Inc. | 2007-06-05 | Traditional | PDF ↗ |
| K061104 | SPEECHLINK 100 TYPE 1053 | Gn Otometrics A/S | 2006-05-03 | Traditional | PDF ↗ |
| K050496 | REM440 | Interacoustics A/S, Assens | 2005-04-29 | Traditional | PDF ↗ |
| K041853 | OTOGRAM | Tympany, Inc. | 2004-09-03 | Traditional | PDF ↗ |
| K022510 | FONIX, MODEL 7000 | Frye Electronics, Inc. | 2002-08-27 | Abbreviated | PDF ↗ |
| K012306 | AUDIOSCAN VERIFIT, MODEL VF-1 | Etymonic Design, Inc. | 2001-09-21 | Traditional | PDF ↗ |
| K980377 | FONIX FP35 HEARING AID ANALYZER | Frye Electronics, Inc. | 1998-03-18 | Traditional | PDF ↗ |
| K970324 | GSI SA60 DPOAE SYSTEM | Grason-Stadler, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K960229 | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM | Resound Corp. | 1996-03-07 | Traditional | PDF ↗ |
| K952098 | SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE | Siemens Hearing Instruments, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K943460 | PORTAREM 2000 | Starkey Laboratories, Inc. | 1994-10-21 | Traditional | PDF ↗ |
| K943459 | DESKREM-1000 | Starkey Laboratories, Inc. | 1994-10-21 | Traditional | PDF ↗ |
| K943607 | INTERACOUSTICS HEARING AID ANALYZER MS 40 | Precision Acoustics Ind., Inc. | 1994-09-23 | Traditional | PDF ↗ |
| K941848 | INTERACOUSTICS. HEARING AID ANALYZER | Precision Acoustics Ind., Inc. | 1994-05-23 | Traditional | PDF ↗ |
| K934342 | GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM | Glaser Instruments AG | 1994-01-21 | Traditional | PDF ↗ |
| K935400 | FONIX 3500 HEARING AID ANALYZER | Frye Electronics, Inc. | 1994-01-14 | Traditional | PDF ↗ |
| K902244 | RASTRONICS CCI 8 | Rastronics USA, Inc. | 1990-10-05 | Traditional | PDF ↗ |
| K902252 | RASTRONICS CCI 10/3 HEARING AID ANALYSIS | Rastronics USA, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K896996 | CAS (COMPUTERIZED ANALYZER SYSTEM) | Gn Danavox, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K896477 | NICOLET REAL EAR ANALYZER | Nicolet Instrument Corp. | 1990-02-08 | Traditional | PDF ↗ |
| K895383 | TYPE FP40 DIGITAL HEARING AID ANALYZER | Frye Electronics, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K896301 | MODEL 340 PROBE MIC SYSTEM | Virtual Corp. | 1990-01-16 | Traditional | PDF ↗ |
| K884046 | AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 | Etymonic Design, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K884372 | MADSEN IGO1500 INSERTION GAIN OPTIMIZER | Madsen Electronics (Canada) , Ltd. | 1989-02-13 | Traditional | PDF ↗ |
| K884371 | MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM | Madsen Electronics (Canada) , Ltd. | 1989-02-13 | Traditional | PDF ↗ |
| K872633 | MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM | Hearing Health Care Program | 1987-09-16 | Traditional | PDF ↗ |
| K872242 | TYPE 6400 REAL EAR HEARING AID ANALYZER | Frye Electronics, Inc. | 1987-07-10 | Traditional | PDF ↗ |
| K870337 | AUDIOMETER | Bio-Logic Systems Corp. | 1987-04-16 | Traditional | PDF ↗ |
| K870229 | HEARING AID TEST SYSTEM MODEL HAT 1000 | Madsen Electronics (Canada) , Ltd. | 1987-03-13 | Traditional | PDF ↗ |
| K862026 | HA-2000 REAL EAR SPECTROSCOPE | And/Or Corp. | 1986-08-15 | Traditional | PDF ↗ |
| K862162 | PHONIC EAR, MODEL PE 1800 | Phonic Ear, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K862086 | IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 | A/S Bruel & Kjaer | 1986-07-16 | Traditional | PDF ↗ |
| K861857 | PHONIC EAR | Phonic Ear, Inc. | 1986-06-09 | Traditional | PDF ↗ |
| K861571 | TYPE 6500 HEARING AID ANALYZER | Frye Electronics, Inc. | 1986-05-30 | Traditional | PDF ↗ |
| K861113 | ER-7C CLINICAL PROBE MICROPHONE | Etymotic Research | 1986-04-23 | Traditional | PDF ↗ |
| K854535 | INSERTION GAIN OPTIMIZER IGO-1000 | Madsen Electronics (Canada) , Ltd. | 1986-02-20 | Traditional | PDF ↗ |
| K853271 | HEARING AID ANALYSIS SYSTEM | Robert Bosch Corp. | 1986-01-16 | Traditional | PDF ↗ |
| K853320 | FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 | Rastronics USA, Inc. | 1985-09-27 | Traditional | PDF ↗ |
| K850918 | TYPE FP30 DIGITAL HEARING AID ANALYZER | Frye Electronics, Inc. | 1985-05-29 | Traditional | PDF ↗ |
| K844275 | STARKET MODEL HMS | Starkey Laboratories, Inc. | 1984-12-03 | Traditional | PDF ↗ |
| K821908 | STARKEY MODEL HAL-1 | Starkey Laboratories, Inc. | 1982-08-03 | Traditional | PDF ↗ |
| K801905 | FONIX TYPE 5100 HEARING AID ANALYZER | Frye Electronics, Inc. | 1980-08-27 | Traditional | PDF ↗ |
Product code ETW · Class II · Ear, Nose, Throat. Data: openFDA.