510(k) DEN230045
DEN230045 is an FDA 510(k) premarket notification submitted by Sound Health Systems, Inc. for the device "Sonu". The FDA issued a decision of De Novo Granted on December 4, 2023. The device falls under product code QZC (External Mechanical Stimulator For The Relief Of Congestion), a Class II device regulated under 21 CFR 874.6010. Sound Health Systems, Inc. has at least 1 other 510(k) clearance on record.
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.