K190050 is an FDA 510(k) clearance for the Tech Dots - Adhesive and conductive gel. This device is classified as a Media, Electroconductive (Class II - Special Controls, product code GYB).
Submitted by Spes Medica Srl (Battipaglia (Sa), IT). The FDA issued a Cleared decision on July 19, 2019, 190 days after receiving the submission on January 10, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1275.
| 510(k) Number | K190050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2019 |
| Decision Date | July 19, 2019 |
| Days to Decision | 190 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 |