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ETY — Tester, Auditory Impedance Class II

FDA Device Classification

Classification Details

Product Code
ETY
Device Class
Class II
Regulation Number
874.1090
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K183201db diagnostic systemsHearing Healthcare ProMarch 6, 2019
K171038db diagnostic systemsHearing Healthcare ProAugust 2, 2017
K162210maico diagnosticstouchTympNovember 16, 2016
K161707gn otometricsMadsen ZodiacSeptember 1, 2016
K151616interacousticsAT235July 15, 2015
K151509diagnostic group, dba grason-stadlerGSI TympStar Pro Middle Ear AnalyzerJune 25, 2015
K133013inventisINVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PJanuary 24, 2014
K121847interacousticsTITANNovember 29, 2012
K083861interacousticsTITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODApril 9, 2009
K081841amplivoxAMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETERJuly 16, 2008
K070312innovia medicalEARCHECK ACOUSTIC REFLECTOMETERMarch 2, 2007
K033645gn otometricsOTOFLEX 100 TYE 1012March 31, 2004
K031978amplaidAMPLAID A756 SCREENING ADMITTANCE METERJuly 21, 2003
K022728interacoustics a/s, assensAUDIOTRAVELLER, MODEL AA222October 11, 2002
K000097grason-stadlerGSI 2000 MIDDLE EAR ANALYZERApril 12, 2000
K994254international distributors of electronics for mediINTERACOUSTICS AT235 IMPEDANCE AUDIOMETERMarch 14, 2000
K991562pascal medicalPASCAL MEDICAL AB MENIETT 20December 28, 1999
K992370amplifonAMPLAID A724 AND A728September 20, 1999
K990652idem (int'l dist. of electronics for medicine)INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETERMay 17, 1999
K990585idem (int'l dist. of electronics for medicine)INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETERMay 17, 1999