K140777 is an FDA 510(k) clearance for the ZQUIET-SA. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Sleeping Well, LLC (Leola, US). The FDA issued a Cleared decision on July 25, 2014, 119 days after receiving the submission on March 28, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K140777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2014 |
| Decision Date | July 25, 2014 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| 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 |