FDA 510(k) Application Details - DEN180026

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180026
Device Name	Bose Hearing Aid
Applicant	Bose Corporation The Mountain Framingham, MA 01701 US Other 510(k) Applications for this Company
Contact	James Yeagle Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2018
Decision Date	10/05/2018
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review