510(k) DEN230045
- Device
- Sonu
- Applicant
- Sound Health Systems, Inc.
- 510(k) number
- DEN230045
- Product code
- QZC
- Decision
- Unknown (DENG)
- Decision date
- 2023-12-04
- Date received
- 2023-06-16
- Regulation
- 874.6010
- Classification name
- External Mechanical Stimulator For The Relief Of Congestion
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact
- Contact
- Parameswaran Gopi
- Address
- 650-B Fremont Ave., #363 Los Altos CA US 94024 94024
FDA Registration Numbers
- 3008293988
- 3030266327
- 3001149827
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 10860009781259 | Sonu (Gray Headband) | Sound Health Systems Inc | 2024-03-09 |
| 00860009781207 | Sonu (Black Headband) | Sound Health Systems Inc | 2024-03-09 |
Other 510(k) Records For Product Code QZC
| 510(k) | Device | Applicant | Decision date |
|---|
| K242214 | Sonu | Sound Health Systems, Inc. | 2025-04-24 |