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510(k) DEN230045

Sonu by Sound Health Systems, Inc. — Product Code QZC

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 4, 2023
Date Received: June 16, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: External Mechanical Stimulator For The Relief Of Congestion
Device Class: Class II
Regulation Number: 874.6010
Review Panel: EN
Submission Type

The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.