K233754
- 510(k) number
- K233754
- Device name
- AIO Breathe
- Applicant
- Aiomega, LLC TX · US
- Product code
- LQZ — Device, Jaw Repositioning
- Decision date
- 2024-02-23
- Date received
- 2023-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K233754.pdf
Official FDA record: K233754
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.