K110223 is an FDA 510(k) clearance for the WAVEGUARD (TM) EEG CAP. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Eemagine Medical Imaging Solutions GmbH (Naples, US). The FDA issued a Cleared decision on June 29, 2011, 155 days after receiving the submission on January 25, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K110223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2011 |
| Decision Date | June 29, 2011 |
| Days to Decision | 155 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 |