K241160 is an FDA 510(k) clearance for the CAIs Sensor (CAIs-001). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Brainu Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on December 13, 2024, 231 days after receiving the submission on April 26, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K241160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2024 |
| Decision Date | December 13, 2024 |
| Days to Decision | 231 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 |