K211315 is an FDA 510(k) clearance for the Comby EEG Caps. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Pamel D.O.O (Zagreb, HR). The FDA issued a Cleared decision on November 9, 2021, 193 days after receiving the submission on April 30, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K211315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2021 |
| Decision Date | November 09, 2021 |
| Days to Decision | 193 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 |