Panels › Ear, Nose, Throat › Product code ETY · Class 2
Tester, Auditory Impedance
Regulation 874.1090
0510(k)s in 12 months (70 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in ETY
| Company | 510(k)s | Recalls |
|---|---|---|
| American Electromedics Corp. | 12 | 0 |
| Maico Hearing Instruments, Inc. | 5 | 0 |
| Teledyne Avionics Div. of Teledyne | 5 | 0 |
| Idem (Int'L Dist. of Electronics For Medicine) | 3 | 0 |
| Madsen Electronics (Canada) , Ltd. | 3 | 0 |
| Amplaid | 2 | 0 |
| Amplifon S.P.A. | 2 | 0 |
| Db Diagnostic Systems, Inc. | 2 | 0 |
| Endeco Medical, Inc. | 2 | 0 |
| Grason-Stadler, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 2019 | K183201 | Hearing Healthcare Pro Db Diagnostic Systems, Inc. | ETY |
| Aug 2, 2017 | K171038 | Hearing Healthcare Pro Db Diagnostic Systems, Inc. | ETY |
| Nov 16, 2016 | K162210 | touchTymp Maico Diagnostics GmbH, DE | ETY |
| Sep 1, 2016 | K161707 | Madsen Zodiac Gn Otometrics, DK | ETY |
| Jul 15, 2015 | K151616 | AT235 Interacoustics A/S, DK | ETY |
| Jun 25, 2015 | K151509 | GSI TympStar Pro Middle Ear Analyzer Diagnostic Group, Dba Grason-Stadler | ETY |
| Jan 24, 2014 | K133013 | INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE Inventis S.R.L., IT | ETY |
| Nov 29, 2012 | K121847 | TITAN Interacoustics A/S, DK | ETY |
| Apr 9, 2009 | K083861 | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE Interacoustics AS, DK | ETY |
| Jul 16, 2008 | K081841 | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER Amplivox, Ltd. | ETY |
| Mar 2, 2007 | K070312 | EARCHECK ACOUSTIC REFLECTOMETER Innovia Medical, LLC | ETY |
| Mar 31, 2004 | K033645 | OTOFLEX 100 TYE 1012 Gn Otometrics A/S, DK | ETY |
| Jul 21, 2003 | K031978 | AMPLAID A756 SCREENING ADMITTANCE METER Amplaid | ETY |
| Oct 11, 2002 | K022728 | AUDIOTRAVELLER, MODEL AA222 Interacoustics A/S, Assens | ETY |
| Apr 12, 2000 | K000097 | GSI 2000 MIDDLE EAR ANALYZER Grason-Stadler, Inc. | ETY |
| Mar 14, 2000 | K994254 | INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER International Distributors of Electronics For Medi | ETY |
| Dec 28, 1999 | K991562 | PASCAL MEDICAL AB MENIETT 20 Pascal Medical AB | ETY |
| Sep 20, 1999 | K992370 | AMPLAID A724 AND A728 Amplifon S.P.A. | ETY |
| May 17, 1999 | K990652 | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER Idem (Int'L Dist. of Electronics For Medicine) | ETY |
| May 17, 1999 | K990585 | INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER Idem (Int'L Dist. of Electronics For Medicine) | ETY |
| Jan 25, 1999 | K983832 | INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER Idem (Int'L Dist. of Electronics For Medicine) | ETY |
| Nov 18, 1998 | K983051 | AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER American Electromedics Corp. | ETY |
| Nov 18, 1998 | K983049 | AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER American Electromedics Corp. | ETY |
| Nov 17, 1998 | K983046 | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER American Electromedics Corp. | ETY |
| Feb 10, 1998 | K974235 | AMPLAID AM50 Amplifon S.P.A. | ETY |
| Aug 18, 1997 | K971859 | EARCHECK Mdi Instruments, Inc. | ETY |
| May 28, 1997 | K970685 | EARCHECK PRO Mdi Instruments, Inc. | ETY |
| Dec 8, 1995 | K955289 | RACE CAR TYMPANOMETER American Electromedics Corp. | ETY |
| Jul 24, 1995 | K953161 | MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION Maico Hearing Instruments, Inc. | ETY |
| Aug 24, 1994 | K942008 | INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER Precision Acoustics Ind., Inc. | ETY |
| Aug 24, 1994 | K942007 | INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 Precision Acoustics Ind., Inc. | ETY |
| Apr 23, 1993 | K930165 | AE-207D TYMPANOMETER Amrex Electronics, Inc. | ETY |
| Apr 23, 1993 | K930164 | THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S American Electromedics Corp. | ETY |
| Mar 18, 1993 | K923072 | HANDTYMP Life-Tech Intl., Inc. | ETY |
| Feb 19, 1993 | K923073 | AUTOMATIC TYMPANOMETER Life-Tech Intl., Inc. | ETY |
| Feb 2, 1993 | K925585 | GSI 38 AUTO TYMP Lucas Grason-Stadler, Inc. | ETY |
| Jan 21, 1993 | K924934 | AUTOMATIC IMPEDANCE METER AE-205 American Electromedics Corp. | ETY |
| Jan 21, 1993 | K924933 | AE-206 TYMPNOMWRWE(R) AUDIOMETER American Electromedics Corp. | ETY |
| Jun 19, 1991 | K910247 | ZODIAC 901 MIDDLE-EAR ANALYZER Madsen Electronics (Canada) , Ltd. | ETY |
| Apr 30, 1991 | K905704 | MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER Maico Hearing Instruments, Inc. | ETY |
| Mar 29, 1991 | K911095 | GSI 37 AUTO TYMP Lucas Grason-Stadler, Inc. | ETY |
| Feb 20, 1991 | K905213 | MIDDLE EAR ANALYZER, MODEL AE-803 American Electromedics Corp. | ETY |
| Feb 19, 1991 | K905212 | IMMITTANCE METER, MODEL AE-105D/S American Electromedics Corp. | ETY |
| Oct 24, 1990 | K903066 | AMPLAID 770 ADMITTANCE METER Amplus Corp. | ETY |
| Jan 23, 1990 | K894260 | AE-105D DIAGNOSTIC TYMPANOMETER American Electromedics Corp. | ETY |
| Jan 16, 1990 | K895443 | MODEL 210 IMPEDANCE SYSTEM Virtual Corp. | ETY |
| Dec 5, 1989 | K895783 | IMPEDANCE ANALYZER MODELS MD-2, MD-P Singer Medical Products, Inc. | ETY |
| Jun 21, 1989 | K890864 | HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. Rastronics USA, Inc. | ETY |
| Jun 9, 1989 | K883293 | STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT Storz Instrument Co. | ETY |
| Jan 3, 1989 | K883728 | AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER American Electromedics Corp. | ETY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.