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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name external mechanical stimulator for the relief of congestion
De Novo Number DEN230045
Device Name Sonu
Requester
sound health systems, inc.
650-b fremont ave., #363
los altos,  CA  94024
Contact parameswaran gopi
Regulation Number874.6010
Classification Product Code
QZC  
Date Received06/16/2023
Decision Date 12/04/2023
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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