FDA 510(k) Application Details - K981460

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K981460
Device Name	Audiometer
Applicant	MIMOSA ACOUSTICS, INC. 382 FOREST HILL WAY MOUNTAINSIDE, NJ 07092 US Other 510(k) Applications for this Company
Contact	PATRICIA S JENG Other 510(k) Applications for this Contact
Regulation Number	874.1050   More FDA Info for this Regulation Number
Classification Product Code	EWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/1998
Decision Date	05/20/1998
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