FDA 510(k) Application Details - K161562

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K161562
Device Name	Masker, Tinnitus
Applicant	Sound Options Tinnitus Treatments Inc. 3841 Ridgepoint Way Mississauga L5N 7T7 CA Other 510(k) Applications for this Company
Contact	Michael Chrostowski 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	06/06/2016
Decision Date	09/28/2016
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