FDA 510(k) Application Details - K233747

Device Classification Name	More FDA Info for this Device
510(K) Number	K233747
Device Name	Concha Sol Hearing Aids (CL-1001)
Applicant	Concha Labs 55 East 3rd Avenue San Mateo, CA 94401 US Other 510(k) Applications for this Company
Contact	Carlos Bullock 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	11/22/2023
Decision Date	03/15/2024
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