K240463 is an FDA 510(k) clearance for the Slow Wave DS8 (SWDS802). This device is classified as a Mouthguard, Prescription.
Submitted by Slow Wave, Inc. (Spicewood, US). The FDA issued a Cleared decision on June 4, 2024, 109 days after receiving the submission on February 16, 2024.
This device falls under the Dental FDA review panel.
| 510(k) Number | K240463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2024 |
| Decision Date | June 04, 2024 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |