FDA 510(k) Application Details - K083488

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K083488
Device Name	Masker, Tinnitus
Applicant	AUDIFON-USA INC. 403 CHAIRMAN CT., STE. 1 DEBARY, FL 32713 US Other 510(k) Applications for this Company
Contact	JANE E PERRONE Other 510(k) Applications for this Contact
Regulation Number	874.3400   More FDA Info for this Regulation Number
Classification Product Code	KLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2008
Decision Date	02/19/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review