K191975 is an FDA 510(k) clearance for the Elefix V Paste for EEG & EMG. This device is classified as a Media, Electroconductive (Class II - Special Controls, product code GYB).
Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on February 7, 2020, 198 days after receiving the submission on July 24, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1275.
| 510(k) Number | K191975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2019 |
| Decision Date | February 07, 2020 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYB — Media, Electroconductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1275 |