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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
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