FDA 510(k) Application Details - K130937

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K130937
Device Name	Masker, Tinnitus
Applicant	HANSATON AKUSTIK GMBH BEIM STROHHAUSE 17 HAMBURG 20097 DE Other 510(k) Applications for this Company
Contact	NICK BURMESTER 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	04/04/2013
Decision Date	01/03/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review