FDA 510(k) Application Details - K150491

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K150491
Device Name	Audiometer
Applicant	ETYMOTIC RESEARCH, INC. 61 MARTIN LN. ELK GROVE VILLAGE, IL 60007 US Other 510(k) Applications for this Company
Contact	Steve Iseberg 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	02/25/2015
Decision Date	03/26/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review