FDA 510(k) Application Details - K112992

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K112992
Device Name	Audiometer
Applicant	EARLOGIC CORPORATION 8 EAST BROADWAY SUITE 611 SALY LAKE CITY, UT 84111 US Other 510(k) Applications for this Company
Contact	SHIN KUK YOO 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	10/06/2011
Decision Date	04/20/2012
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