Product code ETY
- Device name
- Tester, Auditory Impedance
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.1090
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2019-03-06 |
| K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017-08-02 |
| K162210 | touchTymp | Maico Diagnostics GmbH | 2016-11-16 |
| K161707 | Madsen Zodiac | Gn Otometrics | 2016-09-01 |
| K151616 | AT235 | Interacoustics A/S | 2015-07-15 |
| K151509 | GSI TympStar Pro Middle Ear Analyzer | Diagnostic Group, Dba Grason-Stadler | 2015-06-25 |
| K133013 | INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE | Inventis S.R.L. | 2014-01-24 |
| K121847 | TITAN | Interacoustics A/S | 2012-11-29 |
| K083861 | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE | Interacoustics AS | 2009-04-09 |
| K081841 | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER | Amplivox, Ltd. | 2008-07-16 |
| K070312 | EARCHECK ACOUSTIC REFLECTOMETER | Innovia Medical, LLC | 2007-03-02 |
| K033645 | OTOFLEX 100 TYE 1012 | Gn Otometrics A/S | 2004-03-31 |
| K031978 | AMPLAID A756 SCREENING ADMITTANCE METER | Amplaid | 2003-07-21 |
| K022728 | AUDIOTRAVELLER, MODEL AA222 | Interacoustics A/S, Assens | 2002-10-11 |
| K000097 | GSI 2000 MIDDLE EAR ANALYZER | Grason-Stadler, Inc. | 2000-04-12 |
| K994254 | INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER | International Distributors of Electronics For Medi | 2000-03-14 |
| K991562 | PASCAL MEDICAL AB MENIETT 20 | Pascal Medical AB | 1999-12-28 |
| K992370 | AMPLAID A724 AND A728 | Amplifon S.P.A. | 1999-09-20 |
| K990652 | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-05-17 |
| K990585 | INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-05-17 |
| K983832 | INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-01-25 |
| K983049 | AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER | American Electromedics Corp. | 1998-11-18 |
| K983051 | AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | American Electromedics Corp. | 1998-11-18 |
| K983046 | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER | American Electromedics Corp. | 1998-11-17 |
| K974235 | AMPLAID AM50 | Amplifon S.P.A. | 1998-02-10 |
| K971859 | EARCHECK | Mdi Instruments, Inc. | 1997-08-18 |
| K970685 | EARCHECK PRO | Mdi Instruments, Inc. | 1997-05-28 |
| K955289 | RACE CAR TYMPANOMETER | American Electromedics Corp. | 1995-12-08 |
| K953161 | MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION | Maico Hearing Instruments, Inc. | 1995-07-24 |
| K942007 | INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 | Precision Acoustics Ind., Inc. | 1994-08-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08051597160051 | Resonance | M.R.S. SRL | 2025-09-01 |
| 04260223142994 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2024-05-22 |
| 05060488902673 | Amplivox | AMPLIVOX LIMITED | 2024-01-08 |
| 04260223145308 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2020-06-27 |
| 04260223145292 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2020-06-27 |
| 04260223145247 | Sentiero Advanced | PATH medical GmbH | 2020-06-27 |
| 04260223145230 | Sentiero Advanced | PATH medical GmbH | 2020-06-27 |
| 00732094011968 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2020-06-22 |
| 04260223143359 | Sentiero Desktop AuDX PRO Flex Set | PATH medical GmbH | 2018-04-10 |
| 04260223143311 | NavPro ONE Device with touchscreen | PATH medical GmbH | 2018-04-10 |
| 04260223143304 | AuDX PRO FLEX Device with touchscreen | PATH medical GmbH | 2018-04-10 |
| 04260223141577 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2018-03-31 |
| 04260223141584 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2018-03-31 |
| 04260223142819 | Sentiero Desktop (Auditdata) | PATH medical GmbH | 2017-05-26 |
| 04260223142444 | Sentiero Advanced | PATH medical GmbH | 2017-03-31 |
| 08584270041670 | Maico | Diagnostic Group LLC | 2016-11-10 |
| 00810046700044 | Grason-Stadler | Diagnostic Group LLC | 2016-11-10 |
| 08584270041663 | Maico | Diagnostic Group LLC | 2016-09-24 |
| 05711117082104 | Interacoustics | Interacoustics A/S | 2016-09-24 |
| 00810046700013 | Grason-Stadler | Diagnostic Group LLC | 2016-09-24 |
| 04260223141553 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2016-09-16 |
| 04260223141515 | Sentiero Desktop Screening | PATH medical GmbH | 2016-08-31 |
| 04260223141478 | Sentiero Desktop Screening | PATH medical GmbH | 2016-08-31 |
| 04260223141485 | Sentiero Desktop Screening | PATH medical GmbH | 2016-08-31 |
| 04260223141492 | Sentiero Desktop Screening | PATH medical GmbH | 2016-08-31 |
| 04260223141508 | Sentiero Desktop Screening | PATH medical GmbH | 2016-08-31 |
| 04260223141522 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2016-08-31 |
| 04260223141539 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2016-08-31 |
| 04260223141546 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2016-08-31 |
| 04260223141560 | Sentiero Desktop Diagnostic | PATH medical GmbH | 2016-08-31 |