The following data is part of a premarket notification filed by Zelegent, Inc. with the FDA for Elevo Snoring Intervention Set.
| Device ID | K213475 |
| 510k Number | K213475 |
| Device Name: | Elevo Snoring Intervention Set |
| Classification | Device, Anti-snoring |
| Applicant | Zelegent, Inc. 4250 Executive Square, Suite 675 La Jolla, CA 92037 |
| Contact | David C. Humbert |
| Correspondent | David C. Humbert Zelegent, Inc. 4250 Executive Square, Suite 675 La Jolla, CA 92037 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-29 |
| Decision Date | 2022-01-27 |