K812418 is an FDA 510(k) clearance for the MEDTRONIC #3798 ELECTRODE. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on September 16, 1981, 23 days after receiving the submission on August 24, 1981.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K812418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1981 |
| Decision Date | September 16, 1981 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |