FDA 510(k) Application Details - K132189

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K132189
Device Name	Hearing Aid, Bone Conduction
Applicant	SOPHONO, INC 5744 CENTRAL AVENUE #100 BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	KRISTA B TRAYNOR Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	LXB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2013
Decision Date	11/22/2013
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