The following data is part of a premarket notification filed by Spes Medica S.r.l. with the FDA for Tech Dots - Adhesive And Conductive Gel.
| Device ID | K190050 |
| 510k Number | K190050 |
| Device Name: | Tech Dots - Adhesive And Conductive Gel |
| Classification | Media, Electroconductive |
| Applicant | Spes Medica S.r.l. Via Europa - Zona Industriale Battipaglia (sa), IT 84091 |
| Contact | Giorgio Facco |
| Correspondent | Giorgio Facco Spes Medica S.r.l. Via Europa - Zona Industriale Battipaglia (sa), IT 84091 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-10 |
| Decision Date | 2019-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054655025627 | K190050 | 000 |