K233754 is an FDA 510(k) clearance for the AIO Breathe. This device is classified as a Device, Jaw Repositioning (Class II - Special Controls, product code LQZ).
Submitted by Aiomega, LLC (Tyler, US). The FDA issued a Cleared decision on February 23, 2024, 93 days after receiving the submission on November 22, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K233754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2023 |
| Decision Date | February 23, 2024 |
| Days to Decision | 93 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQZ - Device, Jaw Repositioning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |