K092942 is an FDA 510(k) clearance for the VITAL SLEEP. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by The Snore Reliever Company, LLC (Laguna Niguel, US). The FDA issued a Cleared decision on January 13, 2010, 111 days after receiving the submission on September 24, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K092942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2009 |
| Decision Date | January 13, 2010 |
| Days to Decision | 111 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 |