K202913 is an FDA 510(k) clearance for the NeuroCap (Model DEC22). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Memory MD, Inc. (Bohemia, US). The FDA issued a Cleared decision on March 5, 2021, 157 days after receiving the submission on September 29, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K202913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2020 |
| Decision Date | March 05, 2021 |
| Days to Decision | 157 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 |