Atlas FDA

ETY

70 FDA 510(k) clearances · Product code

90 daysmedian time to decision
157 days90th percentile
70clearances measured

FDA profile

Official device name
Tester, Auditory Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1090
Medical specialty
Ear, Nose, Throat
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Hearing Healthcare Pro (K183201)Db Diagnostic Systems, Inc.2019-03-06
Hearing Healthcare Pro (K171038)Db Diagnostic Systems, Inc.2017-08-02
touchTymp (K162210)Maico Diagnostics GmbH2016-11-16
Madsen Zodiac (K161707)Gn Otometrics2016-09-01
AT235 (K151616)Interacoustics A/S2015-07-15
GSI TympStar Pro Middle Ear Analyzer (K151509)Diagnostic Group, Dba Grason-Stadler2015-06-25
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE (K133013)Inventis S.R.L.2014-01-24
TITAN (K121847)Interacoustics A/S2012-11-29
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE (K083861)Interacoustics AS2009-04-09
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (K081841)Amplivox, Ltd.2008-07-16
EARCHECK ACOUSTIC REFLECTOMETER (K070312)Innovia Medical, LLC2007-03-02
OTOFLEX 100 TYE 1012 (K033645)Gn Otometrics A/S2004-03-31
AMPLAID A756 SCREENING ADMITTANCE METER (K031978)Amplaid2003-07-21
AUDIOTRAVELLER, MODEL AA222 (K022728)Interacoustics A/S, Assens2002-10-11
GSI 2000 MIDDLE EAR ANALYZER (K000097)Grason-Stadler, Inc.2000-04-12
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER (K994254)International Distributors of Electronics For Medi2000-03-14
PASCAL MEDICAL AB MENIETT 20 (K991562)Pascal Medical AB1999-12-28
AMPLAID A724 AND A728 (K992370)Amplifon S.P.A.1999-09-20
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER (K990585)Idem (Int'L Dist. of Electronics For Medicine)1999-05-17
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER (K990652)Idem (Int'L Dist. of Electronics For Medicine)1999-05-17
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER (K983832)Idem (Int'L Dist. of Electronics For Medicine)1999-01-25
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER (K983049)American Electromedics Corp.1998-11-18
AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER (K983051)American Electromedics Corp.1998-11-18
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER (K983046)American Electromedics Corp.1998-11-17
AMPLAID AM50 (K974235)Amplifon S.P.A.1998-02-10
EARCHECK (K971859)Mdi Instruments, Inc.1997-08-18
EARCHECK PRO (K970685)Mdi Instruments, Inc.1997-05-28
RACE CAR TYMPANOMETER (K955289)American Electromedics Corp.1995-12-08
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION (K953161)Maico Hearing Instruments, Inc.1995-07-24
INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER (K942008)Precision Acoustics Ind., Inc.1994-08-24
INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 (K942007)Precision Acoustics Ind., Inc.1994-08-24
THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S (K930164)American Electromedics Corp.1993-04-23
AE-207D TYMPANOMETER (K930165)Amrex Electronics, Inc.1993-04-23
HANDTYMP (K923072)Life-Tech Intl., Inc.1993-03-18
AUTOMATIC TYMPANOMETER (K923073)Life-Tech Intl., Inc.1993-02-19
GSI 38 AUTO TYMP (K925585)Lucas Grason-Stadler, Inc.1993-02-02
AE-206 TYMPNOMWRWE(R) AUDIOMETER (K924933)American Electromedics Corp.1993-01-21
AUTOMATIC IMPEDANCE METER AE-205 (K924934)American Electromedics Corp.1993-01-21
ZODIAC 901 MIDDLE-EAR ANALYZER (K910247)Madsen Electronics (Canada) , Ltd.1991-06-19
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER (K905704)Maico Hearing Instruments, Inc.1991-04-30
GSI 37 AUTO TYMP (K911095)Lucas Grason-Stadler, Inc.1991-03-29
MIDDLE EAR ANALYZER, MODEL AE-803 (K905213)American Electromedics Corp.1991-02-20
IMMITTANCE METER, MODEL AE-105D/S (K905212)American Electromedics Corp.1991-02-19
AMPLAID 770 ADMITTANCE METER (K903066)Amplus Corp.1990-10-24
AE-105D DIAGNOSTIC TYMPANOMETER (K894260)American Electromedics Corp.1990-01-23
MODEL 210 IMPEDANCE SYSTEM (K895443)Virtual Corp.1990-01-16
IMPEDANCE ANALYZER MODELS MD-2, MD-P (K895783)Singer Medical Products, Inc.1989-12-05
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. (K890864)Rastronics USA, Inc.1989-06-21
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT (K883293)Storz Instrument Co.1989-06-09
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER (K883728)American Electromedics Corp.1989-01-03
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020 (K874354)Madsen Electronics (Canada) , Ltd.1988-01-27
NEUROCOM PRESSURE TEST SYSTEM (K871652)Neurocom International, Inc.1987-07-16
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) (K863353)Grason-Stadler, Inc.1986-11-03
WELCH ALLYN TYMPANOMETER (K861516)Welch Allyn, Inc.1986-06-10
TA-6C - PART NUMBER SLZ 7520 (K860262)Teledyne Avionics Div. of Teledyne1986-04-23
AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B (K854043)Teledyne Avionics Div. of Teledyne1985-12-31
MODEL 310 IMPEDANCE SYSTEM (K853863)Virtual Corp.1985-12-18
Z0174, IMPEDANCE AUDIOMETER (K845049)Madsen Electronics (Canada) , Ltd.1985-05-21
AUTOMATIC IMPEDANCE METER TA-7A (K850461)Teledyne Avionics Div. of Teledyne1985-03-25
ACOUSTIC OTOCOPE RECORDER (K850007)Endeco Medical, Inc.1985-03-01
IMPEDANCE/PURE TONE AUDIOMETER MA620 (K841568)Maico Hearing Instruments, Inc.1984-07-18
CLINICAL TYMPANOMETER (K833045)American Electromedics Corp.1983-12-08
MA 610-IMPEDANCE AUDIOMETER (K831754)Maico Hearing Instruments, Inc.1983-07-07
MA600-IMPEDANCE AUDIOMETER (K831755)Maico Hearing Instruments, Inc.1983-07-06
ENDECO ACOUSTIC OTOSCOPE (K830139)Endeco Medical, Inc.1983-03-09
IMPEDANCE METER ON-1 (K823227)Kells Medical, Inc.1982-11-22
AURAL REFLEX INDICATOR (K822566)Kelleher Corp.1982-09-14
AUTO-TYMPANIGRAPH (TA-5A) (K811509)Teledyne Avionics Div. of Teledyne1981-06-16
SELF-RECORDING ADMITTANCE METER 709 (K802097)Amplaid USA, Inc.1980-10-10
ACOUSTIC IMPEDANCE METER, MODEL TA-4D (K801293)Teledyne Avionics Div. of Teledyne1980-06-17

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Every clearance here is in the API, with alerts when new ones post.