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ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems Class II

FDA Device Classification

FDA product code ETW covers "Calibrator, Hearing Aid / Earphone And Analysis Systems", a Class II medical device regulated under 21 CFR 874.3310. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
ETW
Device Class
Class II
Regulation Number
874.3310
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K122028gn otometricsAURICAL HITOctober 23, 2012
K113831auditdataPRIMUS HEARING INSTRUMENT TEST UNITApril 19, 2012
K110286gn otometricsGN OTOMETRICS TYPE 1053 FREEFITApril 28, 2011
K093006frye electronicsFONIX ,MODEL 8000December 30, 2009
K071462siemens hearing instrumentsUNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)June 5, 2007
K061104gn otometricsSPEECHLINK 100 TYPE 1053May 3, 2006
K050496interacoustics a/s, assensREM440April 29, 2005
K041853tympanyOTOGRAMSeptember 3, 2004
K022510frye electronicsFONIX, MODEL 7000August 27, 2002
K012306etymonic designAUDIOSCAN VERIFIT, MODEL VF-1September 21, 2001
K980377frye electronicsFONIX FP35 HEARING AID ANALYZERMarch 18, 1998
K970324grason-stadlerGSI SA60 DPOAE SYSTEMJune 6, 1997
K960229resoundRESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEMMarch 7, 1996
K952098siemens hearing instrumentsSIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UMay 25, 1995
K943459starkey laboratoriesDESKREM-1000October 21, 1994
K943460starkey laboratoriesPORTAREM 2000October 21, 1994
K943607precision acoustics indINTERACOUSTICS HEARING AID ANALYZER MS 40September 23, 1994
K941848precision acoustics indINTERACOUSTICS. HEARING AID ANALYZERMay 23, 1994
K934342glaser instrumentsGLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEMJanuary 21, 1994
K935400frye electronicsFONIX 3500 HEARING AID ANALYZERJanuary 14, 1994

FDA data resources