K181107 is an FDA 510(k) clearance for the Elevo® Kit Snoring Intervention Device. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Zelegent, Inc. (Irvine, US). The FDA issued a Cleared decision on December 6, 2018, 224 days after receiving the submission on April 26, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K181107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2018 |
| Decision Date | December 06, 2018 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |