K223901 is an FDA 510(k) clearance for the ApneaRX Pro. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Apnea Sciences Coporation (Aliso Viejo, US). The FDA issued a Cleared decision on September 1, 2023, 247 days after receiving the submission on December 28, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K223901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2022 |
| Decision Date | September 01, 2023 |
| Days to Decision | 247 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |