K240575 is an FDA 510(k) clearance for the WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Eemagine Medical Imaging Solutions GmbH (Berlin, DE). The FDA issued a Cleared decision on November 25, 2024, 269 days after receiving the submission on March 1, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K240575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2024 |
| Decision Date | November 25, 2024 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |