K233497 is an FDA 510(k) clearance for the Rest Assure System. This device is classified as a Sleep Appliances With Patient Monitoring (Class II - Special Controls, product code PLC).
Submitted by Somnomed, Inc. (Plano, US). The FDA issued a Cleared decision on October 3, 2024, 338 days after receiving the submission on October 31, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570. For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy..
| 510(k) Number | K233497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2023 |
| Decision Date | October 03, 2024 |
| Days to Decision | 338 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PLC - Sleep Appliances With Patient Monitoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
| Definition | For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy. |