FDA 510(k) Application Details - K172460

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K172460
Device Name	Hearing Aid, Bone Conduction
Applicant	MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck 6020 AT Other 510(k) Applications for this Company
Contact	Elizabeth Gfoeller 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	08/14/2017
Decision Date	04/27/2018
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