FDA 510(k) Application Details - K984243

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K984243
Device Name	Masker, Tinnitus
Applicant	TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH MINNEAPOLIS, MN 55420 US Other 510(k) Applications for this Company
Contact	TOM SCHELLER 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	11/27/1998
Decision Date	01/21/1999
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