FDA 510(k) Application Details - K242214

Device Classification Name	More FDA Info for this Device
510(K) Number	K242214
Device Name	Sonu
Applicant	Sound Health Systems, Inc. 650B Fremont Avenue #363 Los Altos, CA 94024 US Other 510(k) Applications for this Company
Contact	Parameswaran Gopi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2024
Decision Date	04/24/2025
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