FDA 510(k) Applications for Medical Device Product Code "ETY"
(Tester, Auditory Impedance)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K983049 | AMERICAN ELECTROMEDICS CORP. | AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER | 11/18/1998 |
| K983051 | AMERICAN ELECTROMEDICS CORP. | AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | 11/18/1998 |
| K983046 | AMERICAN ELECTROMEDICS CORP. | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER | 11/17/1998 |
| K031978 | AMPLAID | AMPLAID A756 SCREENING ADMITTANCE METER | 07/21/2003 |
| K992370 | AMPLIFON S.P.A. | AMPLAID A724 AND A728 | 09/20/1999 |
| K974235 | AMPLIFON S.P.A. | AMPLAID AM50 | 02/10/1998 |
| K081841 | AMPLIVOX, LTD. | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER | 07/16/2008 |
| K171038 | dB Diagnostic Systems, Inc. | Hearing Healthcare Pro | 08/02/2017 |
| K183201 | dB Diagnostic Systems, Inc. | Hearing Healthcare Pro | 03/06/2019 |
| K151509 | Diagnostic Group, dba Grason-Stadler | GSI TympStar Pro Middle Ear Analyzer | 06/25/2015 |
| K161707 | GN OTOMETRICS | Madsen Zodiac | 09/01/2016 |
| K033645 | GN OTOMETRICS A/S | OTOFLEX 100 TYE 1012 | 03/31/2004 |
| K000097 | GRASON-STADLER, INC. | GSI 2000 MIDDLE EAR ANALYZER | 04/12/2000 |
| K990585 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) | INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER | 05/17/1999 |
| K990652 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER | 05/17/1999 |
| K983832 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) | INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER | 01/25/1999 |
| K070312 | INNOVIA MEDICAL, LLC | EARCHECK ACOUSTIC REFLECTOMETER | 03/02/2007 |
| K151616 | INTERACOUSTICS A/S | AT235 | 07/15/2015 |
| K121847 | INTERACOUSTICS A/S | TITAN | 11/29/2012 |
| K022728 | INTERACOUSTICS A/S, ASSENS | AUDIOTRAVELLER, MODEL AA222 | 10/11/2002 |
| K083861 | INTERACOUSTICS AS | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE | 04/09/2009 |
| K994254 | INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI | INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER | 03/14/2000 |
| K133013 | INVENTIS SRL | INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE | 01/24/2014 |
| K162210 | MAICO DIAGNOSTICS GMBH | touchTymp | 11/16/2016 |
| K971859 | MDI INSTRUMENTS, INC. | EARCHECK | 08/18/1997 |
| K970685 | MDI INSTRUMENTS, INC. | EARCHECK PRO | 05/28/1997 |
| K991562 | PASCAL MEDICAL AB | PASCAL MEDICAL AB MENIETT 20 | 12/28/1999 |
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