K232735 is an FDA 510(k) clearance for the EMA 3D. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Ema Sleep Incorporated (Spicewood, US). The FDA issued a Cleared decision on May 3, 2024, 239 days after receiving the submission on September 7, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K232735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2023 |
| Decision Date | May 03, 2024 |
| Days to Decision | 239 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 |