FDA Product Code
FDA Product Code ETY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.1090
510(k) Clearances — 70 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2019-03-06 | Traditional | PDF ↗ |
| K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017-08-02 | Traditional | PDF ↗ |
| K162210 | touchTymp | Maico Diagnostics GmbH | 2016-11-16 | Special | PDF ↗ |
| K161707 | Madsen Zodiac | Gn Otometrics | 2016-09-01 | Special | PDF ↗ |
| K151616 | AT235 | Interacoustics A/S | 2015-07-15 | Special | PDF ↗ |
| K151509 | GSI TympStar Pro Middle Ear Analyzer | Diagnostic Group, Dba Grason-Stadler | 2015-06-25 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K121847 | TITAN | Interacoustics A/S | 2012-11-29 | Traditional | PDF ↗ |
| K083861 | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE | Interacoustics AS | 2009-04-09 | Traditional | PDF ↗ |
| K081841 | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER | Amplivox, Ltd. | 2008-07-16 | Traditional | PDF ↗ |
| K070312 | EARCHECK ACOUSTIC REFLECTOMETER | Innovia Medical, LLC | 2007-03-02 | Special | PDF ↗ |
| K033645 | OTOFLEX 100 TYE 1012 | Gn Otometrics A/S | 2004-03-31 | Traditional | PDF ↗ |
| K031978 | AMPLAID A756 SCREENING ADMITTANCE METER | Amplaid | 2003-07-21 | Special | PDF ↗ |
| K022728 | AUDIOTRAVELLER, MODEL AA222 | Interacoustics A/S, Assens | 2002-10-11 | Traditional | PDF ↗ |
| K000097 | GSI 2000 MIDDLE EAR ANALYZER | Grason-Stadler, Inc. | 2000-04-12 | Abbreviated | PDF ↗ |
| K994254 | INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER | International Distributors of Electronics For Medi | 2000-03-14 | Traditional | PDF ↗ |
| K991562 | PASCAL MEDICAL AB MENIETT 20 | Pascal Medical AB | 1999-12-28 | Traditional | PDF ↗ |
| K992370 | AMPLAID A724 AND A728 | Amplifon S.P.A. | 1999-09-20 | Traditional | PDF ↗ |
| K990652 | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-05-17 | Traditional | PDF ↗ |
| K990585 | INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-05-17 | Traditional | PDF ↗ |
| K983832 | INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-01-25 | Traditional | PDF ↗ |
| K983049 | AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER | American Electromedics Corp. | 1998-11-18 | Traditional | PDF ↗ |
| K983051 | AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | American Electromedics Corp. | 1998-11-18 | Traditional | PDF ↗ |
| K983046 | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER | American Electromedics Corp. | 1998-11-17 | Traditional | PDF ↗ |
| K974235 | AMPLAID AM50 | Amplifon S.P.A. | 1998-02-10 | Traditional | PDF ↗ |
| K971859 | EARCHECK | Mdi Instruments, Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K970685 | EARCHECK PRO | Mdi Instruments, Inc. | 1997-05-28 | Traditional | PDF ↗ |
| K955289 | RACE CAR TYMPANOMETER | American Electromedics Corp. | 1995-12-08 | Traditional | PDF ↗ |
| K953161 | MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION | Maico Hearing Instruments, Inc. | 1995-07-24 | Traditional | PDF ↗ |
| K942007 | INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 | Precision Acoustics Ind., Inc. | 1994-08-24 | Traditional | PDF ↗ |
| K942008 | INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER | Precision Acoustics Ind., Inc. | 1994-08-24 | Traditional | PDF ↗ |
| K930165 | AE-207D TYMPANOMETER | Amrex Electronics, Inc. | 1993-04-23 | Traditional | PDF ↗ |
| K930164 | THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S | American Electromedics Corp. | 1993-04-23 | Traditional | PDF ↗ |
| K923072 | HANDTYMP | Life-Tech Intl., Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K923073 | AUTOMATIC TYMPANOMETER | Life-Tech Intl., Inc. | 1993-02-19 | Traditional | PDF ↗ |
| K925585 | GSI 38 AUTO TYMP | Lucas Grason-Stadler, Inc. | 1993-02-02 | Traditional | PDF ↗ |
| K924933 | AE-206 TYMPNOMWRWE(R) AUDIOMETER | American Electromedics Corp. | 1993-01-21 | Traditional | PDF ↗ |
| K924934 | AUTOMATIC IMPEDANCE METER AE-205 | American Electromedics Corp. | 1993-01-21 | Traditional | PDF ↗ |
| K910247 | ZODIAC 901 MIDDLE-EAR ANALYZER | Madsen Electronics (Canada) , Ltd. | 1991-06-19 | Traditional | PDF ↗ |
| K905704 | MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER | Maico Hearing Instruments, Inc. | 1991-04-30 | Traditional | PDF ↗ |
| K911095 | GSI 37 AUTO TYMP | Lucas Grason-Stadler, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K905213 | MIDDLE EAR ANALYZER, MODEL AE-803 | American Electromedics Corp. | 1991-02-20 | Traditional | PDF ↗ |
| K905212 | IMMITTANCE METER, MODEL AE-105D/S | American Electromedics Corp. | 1991-02-19 | Traditional | PDF ↗ |
| K903066 | AMPLAID 770 ADMITTANCE METER | Amplus Corp. | 1990-10-24 | Traditional | PDF ↗ |
| K894260 | AE-105D DIAGNOSTIC TYMPANOMETER | American Electromedics Corp. | 1990-01-23 | Traditional | PDF ↗ |
| K895443 | MODEL 210 IMPEDANCE SYSTEM | Virtual Corp. | 1990-01-16 | Traditional | PDF ↗ |
| K895783 | IMPEDANCE ANALYZER MODELS MD-2, MD-P | Singer Medical Products, Inc. | 1989-12-05 | Traditional | PDF ↗ |
| K890864 | HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. | Rastronics USA, Inc. | 1989-06-21 | Traditional | PDF ↗ |
| K883293 | STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT | Storz Instrument Co. | 1989-06-09 | Traditional | PDF ↗ |
| K883728 | AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER | American Electromedics Corp. | 1989-01-03 | Traditional | PDF ↗ |
| K874354 | AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020 | Madsen Electronics (Canada) , Ltd. | 1988-01-27 | Traditional | PDF ↗ |
| K871652 | NEUROCOM PRESSURE TEST SYSTEM | Neurocom International, Inc. | 1987-07-16 | Traditional | PDF ↗ |
| K863353 | MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) | Grason-Stadler, Inc. | 1986-11-03 | Traditional | PDF ↗ |
| K861516 | WELCH ALLYN TYMPANOMETER | Welch Allyn, Inc. | 1986-06-10 | Traditional | PDF ↗ |
| K860262 | TA-6C - PART NUMBER SLZ 7520 | Teledyne Avionics Div. of Teledyne | 1986-04-23 | Traditional | PDF ↗ |
| K854043 | AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B | Teledyne Avionics Div. of Teledyne | 1985-12-31 | Traditional | PDF ↗ |
| K853863 | MODEL 310 IMPEDANCE SYSTEM | Virtual Corp. | 1985-12-18 | Traditional | PDF ↗ |
| K845049 | Z0174, IMPEDANCE AUDIOMETER | Madsen Electronics (Canada) , Ltd. | 1985-05-21 | Traditional | PDF ↗ |
| K850461 | AUTOMATIC IMPEDANCE METER TA-7A | Teledyne Avionics Div. of Teledyne | 1985-03-25 | Traditional | PDF ↗ |
| K850007 | ACOUSTIC OTOCOPE RECORDER | Endeco Medical, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K841568 | IMPEDANCE/PURE TONE AUDIOMETER MA620 | Maico Hearing Instruments, Inc. | 1984-07-18 | Traditional | PDF ↗ |
| K833045 | CLINICAL TYMPANOMETER | American Electromedics Corp. | 1983-12-08 | Traditional | PDF ↗ |
| K831754 | MA 610-IMPEDANCE AUDIOMETER | Maico Hearing Instruments, Inc. | 1983-07-07 | Traditional | PDF ↗ |
| K831755 | MA600-IMPEDANCE AUDIOMETER | Maico Hearing Instruments, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K830139 | ENDECO ACOUSTIC OTOSCOPE | Endeco Medical, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K823227 | IMPEDANCE METER ON-1 | Kells Medical, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K822566 | AURAL REFLEX INDICATOR | Kelleher Corp. | 1982-09-14 | Traditional | PDF ↗ |
| K811509 | AUTO-TYMPANIGRAPH (TA-5A) | Teledyne Avionics Div. of Teledyne | 1981-06-16 | Traditional | PDF ↗ |
| K802097 | SELF-RECORDING ADMITTANCE METER 709 | Amplaid USA, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K801293 | ACOUSTIC IMPEDANCE METER, MODEL TA-4D | Teledyne Avionics Div. of Teledyne | 1980-06-17 | Traditional | PDF ↗ |
Product code ETY · Class II · Ear, Nose, Throat. Data: openFDA.