K231663 is an FDA 510(k) clearance for the The AVEOtsd (Tongue Stabilizing Device) Mouthpiece. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Innovative Health Technologies (Nz), Ltd. (Dunedin, NZ). The FDA issued a Cleared decision on September 18, 2023, 103 days after receiving the submission on June 7, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K231663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2023 |
| Decision Date | September 18, 2023 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |