K232052 is an FDA 510(k) clearance for the Ceribell Instant EEG Headband. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 8, 2023, 29 days after receiving the submission on July 10, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K232052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2023 |
| Decision Date | August 08, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |