K233497
- 510(k) number
- K233497
- Device name
- Rest Assure System
- Applicant
- Somnomed, Inc. TX · US
- Product code
- PLC — Sleep Appliances With Patient Monitoring
- Decision date
- 2024-10-03
- Date received
- 2023-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K233497.pdf
Official FDA record: K233497
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.