K231663
- 510(k) number
- K231663
- Device name
- The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
- Applicant
- Innovative Health Technologies (Nz), Ltd. NZ
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2023-09-18
- Date received
- 2023-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231663
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.