DEN230045
- 510(k) number
- DEN230045
- Device name
- Sonu
- Applicant
- Sound Health Systems, Inc. CA · US
- Product code
- QZC — External Mechanical Stimulator For The Relief Of Con
- Decision date
- 2023-12-04
- Date received
- 2023-06-16
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Ear, Nose, Throat
Official FDA record: DEN230045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.