FDA 510(k) Application Details - K122876

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K122876
Device Name	Masker, Tinnitus
Applicant	STARKEY LABORATORIES 6600-6700 WASHINGTON AVE SO. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	KEN MEYER 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	09/19/2012
Decision Date	10/31/2012
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	Y
Expedited Review