K192603 is an FDA 510(k) clearance for the Spes Medica Subdermal Needle Electrodes. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Spes Medica Srl (Battipaglia (Sa), IT). The FDA issued a Cleared decision on November 22, 2019, 63 days after receiving the submission on September 20, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K192603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXZ - Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |