K792351 is an FDA 510(k) clearance for the MEDTRONIC MOD. 3852 STERIL-ICE 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 December 5, 1979, 16 days after receiving the submission on November 19, 1979.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K792351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1979 |
| Decision Date | December 05, 1979 |
| Days to Decision | 16 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 |