FDA 510(k) Application Details - K141524

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K141524
Device Name	Audiometer
Applicant	TELEEMG, LLC USA 88 STILES ROAD SALEM, NH 03079 US Other 510(k) Applications for this Company
Contact	BARRY ASHAR 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	06/09/2014
Decision Date	03/12/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review