FDA 510(k) Applications for Medical Device Product Code: ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems)

FDA 510(k) Applications for Medical Device Product Code "ETW"
(Calibrator, Hearing Aid / Earphone And Analysis Systems)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K113831	AUDITDATA A/S	PRIMUS HEARING INSTRUMENT TEST UNIT	04/19/2012
K012306	ETYMONIC DESIGN, INC.	AUDIOSCAN VERIFIT, MODEL VF-1	09/21/2001
K093006	FRYE ELECTRONICS, INC.	FONIX ,MODEL 8000	12/30/2009
K980377	FRYE ELECTRONICS, INC.	FONIX FP35 HEARING AID ANALYZER	03/18/1998
K022510	FRYE ELECTRONICS, INC.	FONIX, MODEL 7000	08/27/2002
K122028	GN OTOMETRICS	AURICAL HIT	10/23/2012
K110286	GN OTOMETRICS A/S	GN OTOMETRICS TYPE 1053 FREEFIT	04/28/2011
K061104	GN OTOMETRICS A/S	SPEECHLINK 100 TYPE 1053	05/03/2006
K970324	GRASON-STADLER, INC.	GSI SA60 DPOAE SYSTEM	06/06/1997
K050496	INTERACOUSTICS A/S, ASSENS	REM440	04/29/2005
K960229	RESOUND CORP.	RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM	03/07/1996
K071462	SIEMENS HEARING INSTRUMENTS, INC.	UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)	06/05/2007
K041853	TYMPANY, INC.	OTOGRAM	09/03/2004