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510(k) K242214

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 24, 2025
Date Received: July 29, 2024
Clearance Type: Traditional
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.