Tester, Auditory Impedance
FDA product code ETY · Class II (moderate risk) · 21 CFR 874.1090 · Ear, Nose, Throat
70510(k) clearances
0PMA approvals
0recalls
Manufacturers
- American Electromedics Corp. 12
- Maico Hearing Instruments, Inc. 5
- Teledyne Avionics Div. of Teledyne 5
- Madsen Electronics (Canada) , Ltd. 3
- Idem (Int'L Dist. of Electronics For Medicine) 3
- Grason-Stadler, Inc. 2
- Mdi Instruments, Inc. 2
- Precision Acoustics Ind., Inc. 2
- Amplifon S.P.A. 2
- Life-Tech Intl., Inc. 2
- Lucas Grason-Stadler, Inc. 2
- Interacoustics A/S 2
- Virtual Corp. 2
- Endeco Medical, Inc. 2
- Db Diagnostic Systems, Inc. 2
- Storz Instrument Co. 1
- Rastronics USA, Inc. 1
- Neurocom International, Inc. 1
- Welch Allyn, Inc. 1
- Kelleher Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183201 | Hearing Healthcare ProETY · Traditional | Db Diagnostic Systems, Inc. | 03/06/2019SE |
| K171038 | Hearing Healthcare ProETY · Traditional | Db Diagnostic Systems, Inc. | 08/02/2017SE |
| K162210 | touchTympETY · Special | Maico Diagnostics GmbH | 11/16/2016SE |
| K161707 | Madsen ZodiacETY · Special | Gn Otometrics | 09/01/2016SE |
| K151616 | AT235ETY · Special | Interacoustics A/S | 07/15/2015SE |
| K151509 | GSI TympStar Pro Middle Ear AnalyzerETY · Traditional | Diagnostic Group, Dba Grason-Stadler | 06/25/2015SE |
| K133013 | Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus…ETY · Traditional | Inventis S.R.L. | 01/24/2014SE |
| K121847 | TitanETY · Traditional | Interacoustics A/S | 11/29/2012SE |
| K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module…ETY · Traditional | Interacoustics AS | 04/09/2009SE |
| K081841 | Amplivox Otowave 102 Hand Held Portable TympanometerETY · Traditional | Amplivox, Ltd. | 07/16/2008SE |
| K070312 | Earcheck Acoustic ReflectometerETY · Special | Innovia Medical, LLC | 03/02/2007SE |
| K033645 | Otoflex 100 Tye 1012ETY · Traditional | Gn Otometrics A/S | 03/31/2004SE |
| K031978 | Amplaid A756 Screening Admittance MeterETY · Special | Amplaid | 07/21/2003SE |
| K022728 | Audiotraveller, Model AA222ETY · Traditional | Interacoustics A/S, Assens | 10/11/2002SE |
| K000097 | Gsi 2000 Middle Ear AnalyzerETY · Abbreviated | Grason-Stadler, Inc. | 04/12/2000SE |
| K994254 | Interacoustics AT235 Impedance AudiometerETY · Traditional | International Distributors of Electronics For Medi | 03/14/2000SE |
| K991562 | Pascal Medical AB Meniett 20ETY · Traditional | Pascal Medical AB | 12/28/1999SE |
| K992370 | Amplaid A724 and A728ETY · Traditional | Amplifon S.P.A. | 09/20/1999SE |
| K990652 | Interacoustics Model AZ26 Clinical Impedance AudiometerETY · Traditional | Idem (Int'L Dist. of Electronics For Medicine) | 05/17/1999SE |
| K990585 | Interacoustics AT22T Automatic Impedance AudiometerETY · Traditional | Idem (Int'L Dist. of Electronics For Medicine) | 05/17/1999SE |
| K983832 | Interacoustics Model MT 10, Handheld Impedance AudiometerETY · Traditional | Idem (Int'L Dist. of Electronics For Medicine) | 01/25/1999SE |
| K983051 | American Electromedics Race Ca Tympanometer/Audiometer with Integral PrinterETY · Traditional | American Electromedics Corp. | 11/18/1998SE |
| K983049 | American Electromedics Quik Tymp 1 (QT1) Tympanometer with Intergral PrinterETY · Traditional | American Electromedics Corp. | 11/18/1998SE |
| K983046 | American Electromedics Race Car Tympanometer W/Integral PrinterETY · Traditional | American Electromedics Corp. | 11/17/1998SE |
| K974235 | Amplaid AM50ETY · Traditional | Amplifon S.P.A. | 02/10/1998SE |
| K971859 | EarcheckETY · Traditional | Mdi Instruments, Inc. | 08/18/1997SE |
| K970685 | Earcheck ProETY · Traditional | Mdi Instruments, Inc. | 05/28/1997SE |
| K955289 | Race Car TympanometerETY · Traditional | American Electromedics Corp. | 12/08/1995SE |
| K953161 | Maico MA630D Audiometer with Optional Reflex Decay & Eustachian Tube FunctionETY · Traditional | Maico Hearing Instruments, Inc. | 07/24/1995SE |
| K942008 | Interacoustics Automatic Impedance AudiometerETY · Traditional | Precision Acoustics Ind., Inc. | 08/24/1994SE |
| K942007 | Interacoustics Clinical Impedance Audiometer AZ26ETY · Traditional | Precision Acoustics Ind., Inc. | 08/24/1994SE |
| K930165 | AE-207D TympanometerETY · Traditional | Amrex Electronics, Inc. | 04/23/1993SE |
| K930164 | The Automatic Impedance Meter,Model AE-208D/SETY · Traditional | American Electromedics Corp. | 04/23/1993SE |
| K923072 | HandtympETY · Traditional | Life-Tech Intl., Inc. | 03/18/1993SE |
| K923073 | Automatic TympanometerETY · Traditional | Life-Tech Intl., Inc. | 02/19/1993SE |
| K925585 | Gsi 38 Auto TympETY · Traditional | Lucas Grason-Stadler, Inc. | 02/02/1993SE |
| K924934 | Automatic Impedance Meter AE-205ETY · Traditional | American Electromedics Corp. | 01/21/1993SE |
| K924933 | AE-206 Tympnomwrwe(R) AudiometerETY · Traditional | American Electromedics Corp. | 01/21/1993SE |
| K910247 | Zodiac 901 Middle-Ear AnalyzerETY · Traditional | Madsen Electronics (Canada) , Ltd. | 06/19/1991SE |
| K905704 | MA630 Imped SCREENER/MA640 Imped/Audiomet ScreenerETY · Traditional | Maico Hearing Instruments, Inc. | 04/30/1991SE |
| K911095 | Gsi 37 Auto TympETY · Traditional | Lucas Grason-Stadler, Inc. | 03/29/1991SE |
| K905213 | Middle Ear Analyzer, Model AE-803ETY · Traditional | American Electromedics Corp. | 02/20/1991SE |
| K905212 | Immittance Meter, Model AE-105D/SETY · Traditional | American Electromedics Corp. | 02/19/1991SE |
| K903066 | Amplaid 770 Admittance MeterETY · Traditional | Amplus Corp. | 10/24/1990SE |
| K894260 | AE-105D Diagnostic TympanometerETY · Traditional | American Electromedics Corp. | 01/23/1990SE |
| K895443 | Model 210 Impedance SystemETY · Traditional | Virtual Corp. | 01/16/1990SE |
| K895783 | Impedance Analyzer Models MD-2, Md-PETY · Traditional | Singer Medical Products, Inc. | 12/05/1989SE |
| K890864 | Handtymp Screener Model 2000 + 2002 Remote Trans.ETY · Traditional | Rastronics USA, Inc. | 06/21/1989SE |
| K883293 | Storz DX Center:Impedance Test W/Rhino & Audio OptETY · Traditional | Storz Instrument Co. | 06/09/1989SE |
| K883728 | Auto Impedance Meter AE105 & AE106 W/AudiometerETY · Traditional | American Electromedics Corp. | 01/03/1989SE |
| K874354 | Audiometric Impedance Tester, Model Z02020ETY · Traditional | Madsen Electronics (Canada) , Ltd. | 01/27/1988SE |
| K871652 | Neurocom Pressure Test SystemETY · Traditional | Neurocom International, Inc. | 07/16/1987SE |
| K863353 | Middle Ear Analyzer (Impedance Audiometer)ETY · Traditional | Grason-Stadler, Inc. | 11/03/1986SE |
| K861516 | Welch Allyn TympanometerETY · Traditional | Welch Allyn, Inc. | 06/10/1986SE |
| K860262 | TA-6C - Part Number SLZ 7520ETY · Traditional | Teledyne Avionics Div. of Teledyne | 04/23/1986SE |
| K854043 | Automatic Impedance Audiometer, TA-7BETY · Traditional | Teledyne Avionics Div. of Teledyne | 12/31/1985SE |
| K853863 | Model 310 Impedance SystemETY · Traditional | Virtual Corp. | 12/18/1985SE |
| K845049 | Z0174, Impedance AudiometerETY · Traditional | Madsen Electronics (Canada) , Ltd. | 05/21/1985SE |
| K850461 | Automatic Impedance Meter TA-7AETY · Traditional | Teledyne Avionics Div. of Teledyne | 03/25/1985SE |
| K850007 | Acoustic Otocope RecorderETY · Traditional | Endeco Medical, Inc. | 03/01/1985SE |
| K841568 | Impedance/Pure Tone Audiometer MA620ETY · Traditional | Maico Hearing Instruments, Inc. | 07/18/1984SE |
| K833045 | Clinical TympanometerETY · Traditional | American Electromedics Corp. | 12/08/1983SE |
| K831754 | Ma 610-IMPEDANCE AudiometerETY · Traditional | Maico Hearing Instruments, Inc. | 07/07/1983SE |
| K831755 | MA600-IMPEDANCE AudiometerETY · Traditional | Maico Hearing Instruments, Inc. | 07/06/1983SE |
| K830139 | Endeco Acoustic OtoscopeETY · Traditional | Endeco Medical, Inc. | 03/09/1983SE |
| K823227 | Impedance Meter ON-1ETY · Traditional | Kells Medical, Inc. | 11/22/1982SE |
| K822566 | Aural Reflex IndicatorETY · Traditional | Kelleher Corp. | 09/14/1982SE |
| K811509 | Auto-Tympanigraph (TA-5A)ETY · Traditional | Teledyne Avionics Div. of Teledyne | 06/16/1981SE |
| K802097 | Self-Recording Admittance Meter 709ETY · Traditional | Amplaid USA, Inc. | 10/10/1980SE |
| K801293 | Acoustic Impedance Meter, Model TA-4DETY · Traditional | Teledyne Avionics Div. of Teledyne | 06/17/1980SE |