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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Mechanical Stimulator For The Relief Of Congestion
510(k) Number K242214
Device Name Sonu
Applicant
Sound Health Systems, Inc.
650b Fremont Ave. #363
Los Altos,  CA  94024
Applicant Contact Parameswaran Gopi
Correspondent
RQM+
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Pierre Bounaud
Classification Product Code
QZC  
Date Received07/29/2024
Decision Date 04/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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