K240646 is an FDA 510(k) clearance for the DreamClear. This device is classified as a Amplifier, Physiological Signal (Class II - Special Controls, product code GWL).
Submitted by Somnomed Technologies Inc., Doing Business AS Remware (Tampa, US). The FDA issued a Cleared decision on September 4, 2024, 181 days after receiving the submission on March 7, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K240646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2024 |
| Decision Date | September 04, 2024 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWL - Amplifier, Physiological Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1835 |