FDA 510(k) Application Details - K231550

Device Classification Name	More FDA Info for this Device
510(K) Number	K231550
Device Name	Sontro« OTC Hearing Aids (AI)
Applicant	Soundwave Hearing, LLC 619 Enterprise Drive Suite #205 Oak Brook, IL 60253 US Other 510(k) Applications for this Company
Contact	Anthony Florek 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	05/30/2023
Decision Date	10/26/2023
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