FDA 510(k) Application Details - K053216

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K053216
Device Name	Audiometer
Applicant	MIMOSA ACOUSTICS, INC. 60 HAZELWOOD DR., SUITE #209 CHAMPAIGN, IL 61820 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	11/17/2005
Decision Date	02/10/2006
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