K212325 is an FDA 510(k) clearance for the EEG-acp. This device is classified as a Media, Electroconductive (Class II - Special Controls, product code GYB).
Submitted by Somnomedics GmbH (Randersacker, DE). The FDA issued a Cleared decision on June 15, 2022, 324 days after receiving the submission on July 26, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1275.
| 510(k) Number | K212325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2021 |
| Decision Date | June 15, 2022 |
| Days to Decision | 324 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYB - Media, Electroconductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1275 |