FDA 510(k) Application Details - K013827

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K013827
Device Name	Masker, Tinnitus
Applicant	NEUROSIM LIMITED 13 FUCHSIA ST. BLACKBURN 3130 VICTORIA 3130 AU Other 510(k) Applications for this Company
Contact	IAN BROWN 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	11/19/2001
Decision Date	05/21/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review