FDA 510(k) Application Details - K151025

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K151025
Device Name	Audiometer
Applicant	IHEAR MEDICAL, INC. 15250 HESPERIAN BLVD, STE #102 SAN LEANDRO, CA 94578 US Other 510(k) Applications for this Company
Contact	ANGELA LEE FOREMAN 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	04/16/2015
Decision Date	12/29/2015
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