FDA 510(k) Application Details - K133352

Device Classification Name	Hearing Aid, Group And Auditory Trainer   More FDA Info for this Device
510(K) Number	K133352
Device Name	Hearing Aid, Group And Auditory Trainer
Applicant	HYPERSOUND HEALTH, INC. 13771 DANIELSON ST. STE. L POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	JAMES A BARNES Other 510(k) Applications for this Contact
Regulation Number	874.3320   More FDA Info for this Regulation Number
Classification Product Code	EPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2013
Decision Date	02/12/2014
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