FDA 510(k) Application Details - K043274

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K043274
Device Name	Masker, Tinnitus
Applicant	NEUROMONICS PTY LTD UNIT 10-11/56 NERIDAH ST CHATSWOOD NSW 2067 AU Other 510(k) Applications for this Company
Contact	BEN MCSWEENEY 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	11/26/2004
Decision Date	01/28/2005
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