K200162 is an FDA 510(k) clearance for the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Wuhan Greentek Pty , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on April 21, 2020, 90 days after receiving the submission on January 22, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K200162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2020 |
| Decision Date | April 21, 2020 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |