FDA 510(k) Application Details - K223848

Device Classification Name	More FDA Info for this Device
510(K) Number	K223848
Device Name	IntrisoundÖ Tuned Lumen« 155 Hearing Aids
Applicant	Tuned Ltd 18 Harimon St Gan Yoshiya 3885000 IL Other 510(k) Applications for this Company
Contact	Orit lanco 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	12/22/2022
Decision Date	09/08/2023
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