K223676 is an FDA 510(k) clearance for the SomniCheck. This device is classified as a Amplifier, Physiological Signal (Class II - Special Controls, product code GWL).
Submitted by Brainmatterz, LLC (Richmond, US). The FDA issued a Cleared decision on June 1, 2023, 175 days after receiving the submission on December 8, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K223676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2022 |
| Decision Date | June 01, 2023 |
| Days to Decision | 175 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 |