FDA 510(k) Application Details - DEN230045

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230045
Device Name	Sonu
Applicant	Sound Health Systems, Inc. 650-B Fremont Ave, #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	06/16/2023
Decision Date	12/04/2023
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review