K950314 is an FDA 510(k) clearance for the DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19). This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on March 25, 1996, 424 days after receiving the submission on January 26, 1995.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K950314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1995 |
| Decision Date | March 25, 1996 |
| Days to Decision | 424 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |