FDA 510(k) Application Details - K212609

Device Classification Name	More FDA Info for this Device
510(K) Number	K212609
Device Name	BHA100 Series Braun Clear Hearing Aid
Applicant	Kaz USA, Inc., a Helen of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Matt J. Baun 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	08/17/2021
Decision Date	01/05/2022
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