FDA 510(k) Application Details - K221698

Device Classification Name	More FDA Info for this Device
510(K) Number	K221698
Device Name	Eargo 5 , Eargo 6
Applicant	Eargo, Inc. 2665 North First Street, Suite 300 San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Monica Barrett 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	06/13/2022
Decision Date	12/21/2022
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