FDA 510(k) Application Details - K221064

Device Classification Name	More FDA Info for this Device
510(K) Number	K221064
Device Name	Nuheara IQbuds 2 PRO Hearing Aid
Applicant	Nuheara Limited 13555 S.E. 36th St., Suite 100 Bellevue, WA 98006 US Other 510(k) Applications for this Company
Contact	John Luna Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2022
Decision Date	10/30/2022
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