510(k) K896477
- Device
- NICOLET REAL EAR ANALYZER
- Applicant
- NICOLET INSTRUMENT CORP.
- 510(k) number
- K896477
- Product code
- ETW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-08
- Date received
- 1989-11-13
- Regulation
- 874.3310
- Classification name
- Calibrator, Hearing Aid / Earphone And Analysis Systems
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND T RIDDLE
- Address
- 5225 Verona Rd. Madison WI US 53711 53711
FDA Registration Numbers#
- 3018639
- 3005581270
- 3010611950
- 3013596041
- 3008386587
- 3011310592
- 3030089857
- 9710051
- 3034880867
- 3008699634
- 1058264
- 3005019184
- 8022229
- 9612197
- 3004052117
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ETW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122028 | AURICAL HIT | Gn Otometrics | 2012-10-23 |
| K113831 | PRIMUS HEARING INSTRUMENT TEST UNIT | Auditdata A/S | 2012-04-19 |
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | Gn Otometrics A/S | 2011-04-28 |
| K093006 | FONIX ,MODEL 8000 | Frye Electronics, Inc. | 2009-12-30 |
| K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | Siemens Hearing Instruments, Inc. | 2007-06-05 |
| K061104 | SPEECHLINK 100 TYPE 1053 | Gn Otometrics A/S | 2006-05-03 |
| K050496 | REM440 | Interacoustics A/S, Assens | 2005-04-29 |
| K041853 | OTOGRAM | Tympany, Inc. | 2004-09-03 |
| K022510 | FONIX, MODEL 7000 | Frye Electronics, Inc. | 2002-08-27 |
| K012306 | AUDIOSCAN VERIFIT, MODEL VF-1 | Etymonic Design, Inc. | 2001-09-21 |
| K980377 | FONIX FP35 HEARING AID ANALYZER | Frye Electronics, Inc. | 1998-03-18 |
| K970324 | GSI SA60 DPOAE SYSTEM | Grason-Stadler, Inc. | 1997-06-06 |
| K960229 | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM | Resound Corp. | 1996-03-07 |
| 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 |
| K943460 | PORTAREM 2000 | Starkey Laboratories, Inc. | 1994-10-21 |
Legacy Summary#
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FDA Review#
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