DEN230045 is an FDA 510(k) submission for the Sonu. This device is classified as a External Mechanical Stimulator For The Relief Of Congestion (Class II - Special Controls, product code QZC).
Submitted by Sound Health Systems, Inc. (Los Altos, US). The FDA issued a Not Cleared (DENG) decision on December 4, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.6010. The External Mechanical Stimulator For The Relief Of Congestion Delivers Vibrations To The Sinus And Nasal Areas To Relieve Congestion..
| 510(k) Number | DEN230045 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 16, 2023 |
| Decision Date | December 04, 2023 |
| Days to Decision | 171 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | QZC - External Mechanical Stimulator For The Relief Of Congestion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.6010 |
| Definition | The External Mechanical Stimulator For The Relief Of Congestion Delivers Vibrations To The Sinus And Nasal Areas To Relieve Congestion. |