K243243 is an FDA 510(k) clearance for the Delphi MCS Electrode Cap. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Quantalx Neuroscience, Ltd. (Kfar Sava, IL). The FDA issued a Cleared decision on February 6, 2025, 118 days after receiving the submission on October 11, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K243243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2024 |
| Decision Date | February 06, 2025 |
| Days to Decision | 118 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 |